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Table 1 Schedule of study enrolment, interventions, and assessments

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

 

Study period

Screening

Baseline

Treatment phase

Follow-up phase

Timepoint

-1 week

0

1-day

7-day

14-day

30-day

90-day

Enrolment

 Eligibility screen

×

      

 Informed consent

×

      

 Medical history

×

      

 Physical examination

×

      

 Comorbidity

       

 Allocation

 

×

     

Interventions

 LP5 group

  

×

×

×

  

 Placebo group

  

×

×

×

  

Outcomes

 ASES

 

×

   

×

×

 OSS

 

×

   

×

×

 CMS

 

×

   

×

×

 ROM

 

×

   

×

×

 SF-36

 

×

   

×

×

 PSQI

 

×

×

×

×

×

×

 VAS

 

×

×

×

×

×

×

 PPT

 

×

×

×

×

×

×

Safety assessments

 BRE

 

×

    

×

 URT

 

×

    

×

 LFTs

 

×

    

×

 ESR

 

×

    

×

 ASO

 

×

    

×

 RF

 

×

    

×

 Opioid consumption

 

×

×

×

×

×

×

 Adverse events

 

×

×

×

×

×

×

  1. Abbreviations: LP5 5% Lidocaine patch, ASES American Shoulder and Elbow Surgeons, OSS Oxford Shoulder Score, CMS Constant-Murley, PSQI Pittsburgh Sleep Quality Index, SF-36 36-Item Short Form Survey, VAS Visual analogue scale, PPT Pressure pain threshold, BRE Blood routine examination, URT Urine routine test, LFTs Liver function tests, ESR Erythrocyte sedimentation rate, ASO Anti-streptococcus hemolysinv, RF Rheumatoid factor