Table 1 Outcome definitions and evaluations
Definition | Evaluation | |
|---|---|---|
Primary outcome | ||
The percentages of patients with a complete sensory blockade at 20 min | The combined score is equal to or greater than 7 points. | The sensory blockade of the 4 terminal branches of the brachial plexus is evaluated and graded every 5 min until 30 min after injection using a validated 3-point scale*. |
Most important secondary outcomes | ||
Nerve injury | The percentages of patients who have been associated with persistent paresthesia or weak of the operative upper limb. | 7 days after surgery via post-operation follow-up at the ward or telephone follow-up. |
Incidence of adverse events | The percentages of patients who have been occurred with vascular puncture, Horner syndrome, toxicity of LA, or pneumothorax. | According to drawing with blood, real-time ultrasonic image, and (or) the patient’s symptoms. A detailed description is seen in the footnote£. |
Diaphragmatic paralysis | The excursion of the ipsilateral hemidiaphragm will be measured by ultrasound in supine position via the anterior subcostal route in centimeters. | Using ultrasonic evaluation at 35 min after injection. |
Other secondary outcomes | ||
Imaging time | Defined as the time from initial contact of the ultrasound probe with the skin until obtaining satisfactory imaging. | A stopwatch to calculate |
Needle time | Defined as the time from initial needle insertion until the complete injection of the LA. | A stopwatch to calculate |
Performance time | Defined as the imaging time plus the needle time. | / |
Satisfactory imaging | Defined as more than 4 divisions of the plexus should be visualized as hypoechoic circular structures lateral to the subclavian artery for the CA-SB, and all 3 trunks of the plexus (upper, middle, and lower) for IA-SB. | Real-time ultrasonic image |
Needle pass | Defined as at least 10-mm withdrawal of the needle to retract its trajectory. | During puncture |
Needle visual score | Converted into a 5-point scale§ | Assessment will be made at the time when the first proper position for LA injection is confirmed. |
Procedural-related pain | Converted into the numeric rating scale (NRS) | NRS: 0 = no pain, 10 = worst possible pain |
Difficult level | Converted into the NRS | NRS: 0 = no difficulty, 10 = extremely difficulty |
Surgical anesthesia | Defined as one can tolerate surgical stimulus | During skin incision |
The percentages of patients with a complete sensory or motor blockade | The combined score is equal to or greater than 7 points. | The percentages of patients with complete sensory or motor blockade using a validated 3-point scale# every 5 min until 30 min after injection. |
Sensory onset time | The time point when combined score is equal to or greater than 7 points. | Using a validated 3-point scale every 5 min until 30 min after injection. |
Motor onset time | The time point when combined score is equal to or greater than 7 points. | Using a validated 3-point scale every 5 min until 30 min after injection. |
Sensory-motor onset time | The time point when the combined score is equal to or greater than 14 points. | Using a validated 3-point scale for complete sensory-motor blockade every 5 min until 30 min after injection. |
Duration of the sensory-motor blockade | Converted into the NRS | 0 = normal compare that to the contralateral upper limb, 10 = no feeling or complete in-mobility; sensory-motor blockade return to normal will be defined as NRS<3. |