Efficacy of Local Direct Median Nerve Block

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Anesthesia, Local

• Registration Number: NCT04453462
• Lead Sponsor: Thammasat University

Brief Summary

Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.

Detailed Description

The study is randomized-control trial conducted in single center (Orthopaedic department, Faculty of medicine, Thammasat university) The patients with failed conservative treatment of carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized block-of-4 method.The local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.The patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (Thai version Bonton questionaire)

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-07-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-09-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patient with carpal tunnel syndrome, confirmed by EMG
2. Failed conservative treatment 3 months
3. Age ≥18 years old

Exclusion Criteria

1. Allergic history of xylocaine
2. Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. DM, hypothyroidism, pregnancy, tumor
3. Any patient that has been coverted to open carpal tunnel release

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraoperative pain measured as visual analog scale (VAS)	Immediate postoperative period	Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain; Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale

Secondary Outcome Measures

Name	Time	Method
Postoperative pain measured as visual analog scale (VAS)	2 hours, 4 hours, 6 hours and 12 hours postoperative period	Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain; The pateint is asked to record the 2 hours, 4 hours, 6 hours and 12 hours postoperative pain in case record form.
Functional outcome of the hand measured as Thai Version Boston Questionnaire	2, 4, 12, 24 weeks postoperative period	There are 2 parts of Thai Version Boston Questionnaire; 1. Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome); 2. Functional severity scores (FSS) 8 items (total score 0-40; hign score means worse outcome); The follow up will be 1, 4, 12, 24 weeks to assess functional outcome with Thai Version Boston Questionnaire

Trial Locations

Locations (1)

Thammasat University hospital; 🇹🇭 Khlong Luang, Pathumthani, Thailand