Skip to main content
  • Study protocol
  • Open access
  • Published:

Short-term clinical effectiveness of 5% lidocaine patch after arthroscopic rotator cuff repair: study protocol for a randomized, double-blinded, placebo-controlled clinical trial



Arthroscopic rotator cuff repair (ARCR) often causes unbearable postoperative pain, even more severe than before surgery. Opioids are the drugs of choice for temporary postoperative analgesia. However, this conventional approach also has some side effects and potential for drug abuse. The aims of this study are expected to verify the effect of 5% lidocaine patch (LP5) on the intensity of early postoperative pain, functional recovery and quality of life in patients undergoing ARCR.


In this randomized, double-blind, and placebo-controlled clinical trial, a total of 102 postoperative patients undergoing ARCR will be randomly assigned to either the LP5 group, receiving topical lidocaine analgesia, or the placebo control group. The primary outcome measure will be the change in the American Shoulder Elbow Surgeons score from pre-operation to 90 days post-operation. Secondary outcomes will include pain scores, range of motion, opioid use, safety indicators, blinding assessment and several shoulder function score questionnaires. The effect of the allocated treatment will be assessed at preoperative baseline and at 7-, 14-, 30- and 90-day postoperatively.


In this study, the efficacy and safety of the 5% lidocaine patch will be evaluated in terms of short-term clinical symptoms in patients undergoing ARCR. The results of this study will help determine whether LP5 is effective in early functional recovery in ARCR and whether it relieves pain and reduces opioid consumption.

Trial registration

Chinese Clinical Trial Registry ( ChiCTR2200060108. Registered on 19 May 2022.

Peer Review reports


Arthroscopic rotator cuff repair (ARCR) has been proven to provide excellent clinical outcomes, such as restoration of tendon integrity and improvement in daily living, in patients with symptomatic rotator cuff tears who have failed to respond to conservative treatment [1, 2]. Although the short and long-term clinical outcomes of ARCR are very promising, postoperative pain is strongly associated with early return of mobility and patient satisfaction, particularly in intense postoperative pain [3]. Numerous methods of postoperative pain management after ARCR have been practised clinically, including oral and intravenous medications, regional nerve block, intralesional anaesthesia, periarticular injections [4, 5] and multimodal anaesthesia [6]. Opioids were once the cornerstone of post-ARCR pain management, however, their significant side effects and high addictive potential cannot be ignored as well [7,8,9]. Interscalene brachial plexus block (IBPB) also has some disadvantages, such as short timeliness, technical difficulty and a high probability of recurrence of pain [10, 11].

Five per cent lidocaine patch (LP5) is the first-line recommendation for postherpetic neuralgia and may reduce opioid consumption in acute postoperative pain [12,13,14]. Lidocaine is a voltage-gated sodium channel blocker. The proposed mechanism of action is to block abnormally expressed sodium channels following nerve injury, and lidocaine reduces abnormal peripheral nerve discharge and decreases peripheral sensitivity, thus exerting a local analgesic effect [15, 16]. In addition, the effectiveness of the topical lidocaine patch for other conditions, such as low back and myofascial pain, osteoarthritis of the knee and perioperative pain has been confirmed by previous studies [17,18,19,20,21].

To identify whether the lidocaine patch could produce similar beneficial effects in post-arthroscopic analgesia, we conducted a prospective double-blind randomized trial in patients undergoing ARCR. We hypothesized that lidocaine patch treatment immediately after ARCR would result in clinically and statistically significant improvements in pain levels, functional recovery and the use of oral analgesics.


Trial design

The study will be a prospective, single-centre, randomized, placebo-controlled, double-blind, superiority trial in the First Affiliated Hospital of Soochow University conducted from May 2022 to December 2022, enrolling patients undergoing arthroscopic rotator cuff surgery and was registered in the Chinese Clinical Trial Registry ( ID: ChiCTR2200060108). The study protocol has been approved by our institutional review board, and all subjects provided written informed consent. The flow chart of trial participation is given in Fig. 1.

Fig. 1
figure 1

Study flow chart

Recruitment and informed consent

This study will be conducted in the First Affiliated Hospital of Soochow University. Patients with rotator cuff tears requiring arthroscopic rotator cuff repair (ARCR) will be mobilized from our outpatient centre. After confirming the patient's eligibility for inclusion and completing a baseline level assessment, the investigator will give a detailed presentation of the study protocol and potential risks, etc., and answer all the questions raised by patients and their families. Each patient will sign an informed consent form. Upon enrolment, participants will be coded with a unique number.


All patients confirmed with rotator cuff tear by MRI with symptoms (pain and/or weakness) and are failed to conservative treatments will be included. The exclusion criteria are (1) history of allergy to lidocaine or adhesive, (2) other significant organ disorders or substance abuse, (3) clear radiographic evidence of osteoarthritis of the glenohumeral joint, (4) presence of inflammatory arthritis including rheumatoid, (5) a history of ipsilateral shoulder dislocation or surgery, (6) irreparable tears, (7) pregnancy or heart disease, and (8) inability to understand questionnaires or express the level of pain.

Withdrawal and termination criteria

Participants can withdraw from this trial in the following reasons:

  1. 1.

    Deciding to withdraw by themselves at any time and for any reason.

  2. 2.

    Loss to follow-up.

  3. 3.

    Experiencing serious adverse events or allergic reaction.

Randomization and blinding

Prior to the start of the study, randomization will be performed using a computer-generated table of random numbers by the research pharmacy not involved in the screening of subjects. Included participants will be randomly assigned with a 1:1 allocation to either the lidocaine or placebo group, with each patient having an equal probability of being assigned to either the experimental treatment group or the placebo group. The material, size and colour of the placebo patch will be similar to LP5 as far as possible. Patients will use the patches under the guidance of their surgeons. The group allocation protocols will be enclosed in opaque envelopes to ensure blinding of the investigators, patients, and data analysts. These envelopes will be sealed and could only be opened after the study is completed.

If a subject experiences a serious adverse event or requires emergency resuscitation during the trial, whether or not it is related to the intervention, the intervention received by the subject will be disclosed. Subjects who disclose the intervention will be considered as drop-out cases. If the intervention is disclosed for more than 20% of participants, the trial will not be considered double-blind.

In addition, the allocation scheme of the intervention will be confidential to the evaluators collecting outcome data throughout the study. The statistical analysts will also not know whether participants are in the LP5 or placebo group until the statistical analysis is completed.


The group allocation protocol will be performed prior to the procedure. Based on the random number, a pre-prepared opaque envelope containing either 5% LP measuring 14 × 10 cm2 and containing 700 mg of lidocaine or placebo patches was allocated to the patient. There is no difference between the placebo patches and LP5 patch in appearance or structure, but the placebo does not contain lidocaine. The patch will be divided into strips and applied around the shoulder crest immediately after surgery. The patch will be replaced with a new one every 12 h until 2 weeks postoperatively. Patients, test site medical staff and investigators were blinded to group allocation. In cases of severe shoulder pain, painkillers will be allowed as emergency medication and should be documented in the medical record. Patients will also be asked to record the name, dose, date, frequency and exact time of medication used and to report to the researcher if they have taken any medication during the study. Patient compliance will be maintained and monitored through good communication and constant reminders between medical staff and patients. Although patients will be advised to adhere to the protocol, it is not possible to fully exclude those patients who independently decide to undergo and not report other treatments or measures. We will explain in detail to the patients and their family members simultaneously. A close follow-up and telemedicine will be performed during the trial.

Surgical procedures and postoperative rehabilitation

All ARCR procedures will be performed with the patient in the lateral decubitus position under general anaesthesia. The limb to be operated on is attached to a skin traction device and 3 kg of weight is used to keep the shoulder in a position of 30°–60° of abduction and 20°–30° of flexion. After required arthroscopic portals have been established, an arthroscopic examination will be performed, the hyperplastic bursal tissue and footprint area will be cleared, and acromioplasty will be performed based on intraoperative assessment. The tear will be repaired as clinically indicated for the tear pattern using suture anchors. All patients will receive the same postoperative rehabilitation protocol with the assistance of physical therapists.

Outcomes measurement

Participants will be scheduled for a 3-month follow-up, with data collected at baseline (pre-operative), 1-, 7-, 14-, 30- and 90-day postoperative using a uniform standardized case report form. Baseline clinical data will be collected including age, gender, dominant hand, affected limb, body mass index, comorbidities, body mass index, duration of symptoms, range of motion, previous treatment to the shoulder (including surgery), and details of all treatments within the last 12 months (including the use of intra-articular therapy) (Table 1).

Table 1 Schedule of study enrolment, interventions, and assessments

Primary outcome

The primary outcomes will be the changes from the baseline of the American Shoulder and Elbow Surgeons score (ASES) [22] at the completion of the 90-day follow-up.

Secondary outcome

Functional questionnaire assessment

Participants will complete a series of patient-reported questionnaires at the preoperative, 30-day and 90-day postoperative follow-up points to assess pain, function and patient satisfaction: Oxford Shoulder Score (OSS) [23], the Constant-Murley score (CMS) [24], Pittsburgh Sleep Quality Index (PSQI) [25] and the 36-Item Short Form Survey (SF-36) [26]. In addition to the change in ASES at the terminal follow-up, ASES at other secular nodes will also be included in the secondary outcomes. All measurements will be carried out by an independent blinded assessor.

Range of motion

With the patient standing, active and passive mobility of the affected and unaffected shoulder, including forward elevation (FE), external rotation (ER) and internal rotation (IR), will be recorded using a goniometer. For statistical convenience, active internal rotation of the back will be measured by recording the vertebral levels reached with the tip of the thumb. vertebral levels from T1 to T12 were numbered consecutively as 1 to 12; vertebral levels from L1 to L5 were numbered consecutively as 13 to 17 and any levels below the sacrum were numbered consecutively as 18 [27, 28].

Visual analogue scale

The visual analogue scale [VAS, scale from 0 (no pain) to 10 points (unbearable pain)] will be used to quantify perioperative pain at rest (VASr), pain at night (VASn) and during active movement (VASm).

Mechanical sensitivity

The Mechanical sensitivity will be measured with pressure pain threshold (PPT), defined as the amount of pressure applied for the pressure sensation to first transform to pain. PPT will be assessed using a 10-kgf analogic pressure algometer placed in the footprint area of the rotator cuff (Wagner Instruments, Greenwich, CT, USA). The pressure is slowly increased and the minimum value that allows the subject to report a shift to pain or discomfort is recorded. The average of three repeated measurements, with 30–60s rest intervals, will be calculated for statistical analysis [29, 30].

Plans for collection and use of participant data and biological specimens in this trial/future use

Not applicable, as the study will not use participant data including biological specimens in the future.

Statistical methods

Sample size calculation

There are no reports in the available literature relating to the primary outcome. A pre-trial with a sample size of 60 was conducted in our orthopaedic clinic. 3-month follow-up time results showed ASES scores of 63.56 ± 15.56 and 74.94 ± 18.42 in the control and intervention groups, respectively. With a type I error rate of 0.05 (α = 0.05, two-tail) and a power of 90% (β = 0.10), the sample size for the study protocol was calculated as 41 patients per group based on the primary outcome indicator by PASS 15.0 (Power Analysis and Sample Size, NCSS, LLC, USA). Assuming a 20% drop-out rate, we plan to recruit 102 participants (51 per group) to the study.

Statistical analysis

The final data will be entered and counted by a professional statistician using SPSS 26.0 (IBM, Armonk, NY, USA). For continuous variables, the normality of measured data distributions will be evaluated using the Shapiro-Wilk test. Measurements will be expressed as mean ± standard deviation, if the data are normally distributed with uniform variance. Paired t-tests will be used for within-group comparisons before and after treatment, and independent samples t-tests will be used for between-group comparisons before and after treatment. If the data do not conform to a normal distribution or have an uneven variance, the measurement data will be expressed as median (interquartile range) [M(Q)] and the Wilcoxon rank sum test will be used for the analysis of the data before and after treatment. For categorical variables, chi-square tests or Fisher’s exact tests will be used to examine differences between groups and to describe effect sizes in terms of percentages and frequencies. Prior to any analysis, the pattern and reasons for missing data patterns will be investigated. The primary analysis will be conducted as an intention-to-treat analysis, which includes all participants with missing outcome data, unless there is clear evidence that its underlying assumption is inappropriate. Multivariable imputation by chained equations method will be used to impute missing data for the sensitivity analysis for the primary and secondary outcomes. P<0.05 indicates that the threshold of statistical significance has been reached.

Data collection and management

After meeting all inclusion criteria and agreeing to participate, participants will be coded with a study number and all data referring to the patient will be recorded by this number rather than by name. Patients undergo routine preoperative laboratory and imaging assessments, including a review of preoperative medication and documentation of preoperative opioid use. A Case Report Form (CRF) will be used to collect information from participants, including baseline information, imaging results and follow-up visits. Shoulder mobility, clinical and demographic data, pain scores, and shoulder mobility scores will be collected at follow-up points. Data will also be collected on complications and adverse reactions, including death, reinfection, reoperation, medical complications, rash or allergic reactions. Independent researchers will manually enter the raw data storage. A Data Security Monitoring Board (DSMB) has been set up to review the reliability and security of the data. CRF as well as uploaded data will be stored in a secure cabinet or password-protected folder respectively. Access to study data by other researchers will be restricted. No interim analysis is planned for topical application of 5% lidocaine as the safety concerns are minimal unless required by the Steering Committee or DSMB because of safety concerns.

Acute pain after ARCR is a concern for patients. In addition, a close follow-up and telemedicine will be performed to reduce the rate of loss to follow-up. All patients will be followed up for 3 months for postoperative recovery and monitoring of complications. Patients will receive a text message or email two days before each postoperative follow-up point.

Oversight and monitoring

For this single-centre trial, the trial staff has trained investigators who are responsible for assessing the subgroups and clinical data collection. Providing oversight and guidance for this trial is the Quality Management Office of the First Affiliated Hospital of Soochow University, who will review the data and check the progress of the study.

Quality control

Prior to the trial, all staff will be required to attend a series of training sessions. These sessions will ensure that relevant staff fully understands the study protocol and the standard operating procedures of the study. In order to maintain the consistently high quality of clinical trials, the Clinical Research Centre of the First Hospital of Soochow University will regularly monitor study files, informed consent forms, case report forms (CRFs), serious AEs and data records.

Adverse event management

Any adverse events (AEs) occurring to participants during the clinical trial, whether or not they are related to the intervention, will be assessed and recorded at any time. Adverse events will be recorded on a designated Clinical Case Observation Form (CRF) Adverse Event Form and classified according to the Medical Dictionary of Regulatory Activities (MedDRA). During this period, if the participant feels a slight burning, tingling, redness, blistering or breakage of the local skin, the area will be disinfected and covered with sterile gauze to prevent infection. Other side effects caused by lidocaine such as: hypotension, dizziness, slowed heart rate and gastrointestinal reactions will be recorded on the CRF. Drug safety will be assessed by blood routine examination (BRE), urine routine test (URT), liver function tests (LFTs) and other indicators of significant organ damage. Indicators of joint cavity infection such as erythrocyte sedimentation rate (ESR), anti-streptococcus hemolysinv (ASO) and rheumatoid factor (RF) will be recorded. Data will be collected on complications and adverse reactions, including death, reinfection, reoperation, medical complications, rash or allergic reactions. Serious adverse events (SAEs) will have to be reported to the Ethics Committee of the First Affiliated Hospital of Soochow University within 24 h. In the event of a medical emergency, random coding and group allocation of individuals can be determined through standard operating procedures. These complications will be included in the secondary outcome of this study.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees)

If modifications to the protocol are necessary, these will be submitted to our hospital ethics committee and the Chinese Clinical Trial Registry. Following approval by the relevant units, study participants will be informed that they may withdraw their consent at any time.


This paper presents a double-blind, placebo, randomized controlled trial designed to investigate the efficacy of LP5 for short-term analgesia after ARCR and whether it reduces the consumption of oral opioids. The analgesic effect of the LP5 is mainly due to the blocking of afferent nociceptive transmission. Locally released lidocaine is absorbed by the pain fibres of the skin, blocking sodium channels in the neuronal membrane and preventing the transmission of action potentials from the periphery to the cerebral cortex. In addition, lidocaine inhibits the activation of neutrophils and reduces the release of cytokines, thereby reducing the acute phase of the inflammatory response [31, 32]. There was evidence in the literature to support the view that lidocaine patches were effective in reducing postoperative pain and opioid consumption for laparoscopic gynaecological surgery, appendectomy and radical prostatectomy [12, 20, 33]. However, there is a lack of valid evidence for the effectiveness of ARCR postoperatively. It should be noted that this intervention is low cost and can be conveniently implemented in the postoperative period. One of the limitations of this trial is the small sample size of this trial. Therefore, a multicentre trial with a large sample size is necessary.

Trial status

The trial is currently in the recruitment phase. The study will run from May 2022 to December 2022.

Availability of data and materials

Trial data are available on reasonable request to the principal investigator of the study.



Arthroscopic rotator cuff repair


5% lidocaine patch


Interscalene brachial plexus block


American Shoulder and Elbow Surgeons


Oxford Shoulder Score




Pittsburgh Sleep Quality Index


36-Item Short Form Survey


Forward elevation


External rotation


Internal rotation


Visual analogue scale


Pressure pain threshold


Adverse events


Blood routine examination


Urine routine test


Liver function tests


Erythrocyte sedimentation rate


Anti-streptococcus hemolysin


Rheumatoid factor


Standard deviation


  1. Bhatia S, Greenspoon JA, Horan MP, Warth RJ, Millett PJ. Two-year outcomes after arthroscopic rotator cuff repair in recreational athletes older than 70 years. Am J Sports Med. 2015;43(7):1737–42.

    Article  PubMed  Google Scholar 

  2. Lee SH, Kim JW, Kim TK, Kweon SH, Kang HJ, Kim SJ, et al. Is the arthroscopic suture bridge technique suitable for full-thickness rotator cuff tears of any size? Knee Surg Sports Traumatol Arthrosc. 2017;25(7):2138–46.

    Article  PubMed  Google Scholar 

  3. Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016;25(7):1204–13.

    Article  PubMed  Google Scholar 

  4. Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, et al. Platelet-rich plasma in patients with partial-thickness rotator cuff tears or tendinopathy leads to significantly improved short-term pain relief and function compared with corticosteroid injection: a double-blind randomized controlled trial. Arthroscopy. 2021;37(2):510–7.

    Article  PubMed  Google Scholar 

  5. Weber SC, Kauffman JI, Parise C, Weber SJ, Katz SD. Platelet-rich fibrin matrix in the management of arthroscopic repair of the rotator cuff: a prospective, randomized, double-blinded study. Am J Sports Med. 2013;41(2):263–70.

    Article  PubMed  Google Scholar 

  6. Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP, PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019;74(10):1320–31.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  7. Farley KX, Wilson JM, Spencer CC, Karas S, Xerogeanes J, Gottschalk MB, et al. Preoperative opioid use is a risk factor for revision surgery, complications, and increased resource utilization after arthroscopic rotator cuff repair. Am J Sports Med. 2020;48(13):3339–46.

    Article  PubMed  Google Scholar 

  8. Westermann RW, Anthony CA, Bedard N, Glass N, Bollier M, Hettrich CM, et al. Opioid consumption after rotator cuff repair. Arthroscopy. 2017;33(8):1467–72.

    Article  PubMed  Google Scholar 

  9. Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, et al. Preoperative opioid education has no effect on opioid use in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Am Acad Orthop Surg. 2021;29(19):e961–8.

    Article  PubMed  Google Scholar 

  10. Salviz EA, Xu D, Frulla A, Kwofie K, Shastri U, Chen J, et al. Continuous interscalene block in patients having outpatient rotator cuff repair surgery: a prospective randomized trial. Anesth Analg. 2013;117(6):1485–92.

    Article  PubMed  Google Scholar 

  11. Lee JJ, Hwang JT, Kim DY, Lee SS, Hwang SM, Lee NR, et al. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017;25(7):2121–8.

    Article  PubMed  Google Scholar 

  12. Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, et al. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012;22(7):668–73.

    Article  PubMed  Google Scholar 

  13. Gudin J, Nalamachu S. Utility of lidocaine as a topical analgesic and improvements in patch delivery systems. Postgrad Med. 2020;132(1):28–36.

    Article  PubMed  CAS  Google Scholar 

  14. Smoker J, Cohen A, Rasouli MR, Schwenk ES. Transdermal lidocaine for perioperative pain: a systematic review of the literature. Curr Pain Headache Rep. 2019;23(12):89.

    Article  PubMed  Google Scholar 

  15. Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003;43(2):111–7.

    Article  PubMed  CAS  Google Scholar 

  16. Sawynok J. Topical analgesics for neuropathic pain: preclinical exploration, clinical validation, future development. Eur J Pain. 2014;18(4):465–81.

    Article  PubMed  CAS  Google Scholar 

  17. Baron R, Binder A, Attal N, Casale R, Dickenson AH, Treede RD. Neuropathic low back pain in clinical practice. Eur J Pain. 2016;20(6):861–73.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  18. Affaitati G, Fabrizio A, Savini A, Lerza R, Tafuri E, Costantini R, et al. A randomized, controlled study comparing a lidocaine patch, a placebo patch, and anesthetic injection for treatment of trigger points in patients with myofascial pain syndrome: evaluation of pain and somatic pain thresholds. Clin Ther. 2009;31(4):705–20.

    Article  PubMed  CAS  Google Scholar 

  19. Dworkin RH, Jensen MP, Gould E, Jones BA, Xiang Q, Galer BS, et al. Treatment satisfaction in osteoarthritis and chronic low back pain: the role of pain, physical and emotional functioning, sleep, and adverse events. J Pain. 2011;12(4):416–24.

    Article  PubMed  Google Scholar 

  20. Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, et al. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009;108(6):1950–3.

    Article  PubMed  CAS  Google Scholar 

  21. de Queiroz VKP, da Nóbrega Marinho AM, de Barros GAM. Analgesic effects of a 5% lidocaine patch after cesarean section: a randomized placebo-controlled double-blind clinical trial. J Clin Anesth. 2021;73:110328.

    Article  PubMed  Google Scholar 

  22. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587–94.

    Article  PubMed  Google Scholar 

  23. Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78(4):593–600.

    Article  PubMed  CAS  Google Scholar 

  24. Vrotsou K, Ávila M, Machón M, Mateo-Abad M, Pardo Y, Garin O, et al. Constant-Murley Score: systematic review and standardized evaluation in different shoulder pathologies. Qual Life Res. 2018;27(9):2217–26.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, et al. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013;34(4):511–9.

    Article  PubMed  Google Scholar 

  26. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998;51(11):1025–36.

    Article  PubMed  CAS  Google Scholar 

  27. Kim YK, Jung KH, Won JS, Cho SH. Medialized repair for retracted rotator cuff tears. J Shoulder Elbow Surg. 2017;26(8):1432–40.

    Article  PubMed  Google Scholar 

  28. Mori D, Funakoshi N, Yamashita F. Arthroscopic surgery of irreparable large or massive rotator cuff tears with low-grade fatty degeneration of the infraspinatus: patch autograft procedure versus partial repair procedure. Arthroscopy. 2013;29(12):1911–21.

    Article  PubMed  Google Scholar 

  29. Rodríguez-Huguet M, Góngora-Rodríguez J, Vinolo-Gil MJ, Martín-Vega FJ, Martín-Valero R, Rodríguez-Almagro D. Effectiveness of negative pulsed-pressure myofascial vacuum therapy and therapeutic exercise in chronic non-specific low back pain: a single-blind randomized controlled trial. J Clin Med. 2022;11(7):1984.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Álvarez DM, Serrano-Muñoz D, Fernández-Pérez JJ, Gómez-Soriano J, Avendaño-Coy J. Effect of percutaneous electric stimulation with high-frequency alternating currents on the sensory-motor system of healthy volunteers: a double-blind randomized controlled study. J Clin Med. 2022;11(7):1832.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Saber AA, Elgamal MH, Rao AJ, Itawi EA, Martinez RL. Early experience with lidocaine patch for postoperative pain control after laparoscopic ventral hernia repair. Int J Surg. 2009;7(1):36–8.

    Article  PubMed  Google Scholar 

  32. Derry S, Wiffen PJ, Moore RA, Quinlan J. Topical lidocaine for neuropathic pain in adults. Cochrane Database Syst Rev. 2014;2014(7):CD010958.

    PubMed  PubMed Central  Google Scholar 

  33. Lee W, Hahn K, Hur J, Kim Y. Effect of topical lidocaine patch on postoperative pain management in laparoscopic appendectomy: a randomized, double-blind, prospective study. J Laparoendosc Adv Surg Tech A. 2018;28(9):1061–7.

    Article  PubMed  Google Scholar 

Download references




This work was supported by the National Key Research and Development Program of China (grant number 2022YFE0199900), Clinical Application-oriented Medical Innovation Foundation (grant number 2021-NCRC-CXJJ-PY-09) from National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation and Jiangsu China-Israel Industrial Technical Research Institute Foundation, and Jiangsu Province Science and Technology Innovation Support Plan Project (grant number BZ2022051 ). The funder has no role in the design of the trial; the collection, management, analysis and interpretation of the data; and the writing of the report or the decision to submit it for publication. The funder will fund the study and check the progress of the study at regular intervals throughout the course of the study.

Author information

Authors and Affiliations



JJG: principal investigator, primary protocol author, participant, recruitment, trial steering. YQ: participant recruitment. YX: participant recruitment, protocol co-author. XJ: trial steering and manuscript oversight. The authors read and approved the final manuscript.

Corresponding author

Correspondence to Jiong Jiong Guo.

Ethics declarations

Ethics approval and consent to participate

This trial has been approved by the Ethical Approval Committee of the First Affiliated Hospital of Soochow University. (Approval number 2022-417). The Chinese Clinical Trial Registry granted full approval of the study protocol, recruitment materials, and consent form (URL:; unique identifier: ChiCTR2200060108.

Consent for publication

Trial participants will sign an informed consent form at baseline. Their personal information will be kept strictly confidential.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Qian, Y., Xu, Y., Jin, X. et al. Short-term clinical effectiveness of 5% lidocaine patch after arthroscopic rotator cuff repair: study protocol for a randomized, double-blinded, placebo-controlled clinical trial. Trials 23, 977 (2022).

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: