Efficacy of Local Direct Median Nerve Block

Carpal Tunnel Syndrome Clinical Trial

Official title:

Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453462
• Other study ID #: MTU-EC-OT-6-227/61
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2023
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Carpal Tunnel Syndrome

Intervention

Procedure:
• Endoscopic carpal tunnel release under local direct median nerve block
local direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
• Endoscopic carpal tunnel release under brachial plexus block
brachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)

Locations

Country	Name	City	State
Thailand	Thammasat University hospital	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative pain measured as visual analog scale (VAS)	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	Immediate postoperative period
Secondary	Postoperative pain measured as visual analog scale (VAS)	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.	2 hours, 4 hours, 6 hours and 12 hours postoperative period
Secondary	Functional outcome of the hand measured as Thai Version Boston Questionnaire	There are 2 parts of Thai Version Boston Questionnaire; Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome); 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	2, 4, 12, 24 weeks postoperative period