Efficacy of Local Direct Median Nerve Block

• Sponsor: Thammasat University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04453462
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome; Anesthesia, Local	Procedure: Endoscopic carpal tunnel release under local direct median nerve block; Procedure: Endoscopic carpal tunnel release under brachial plexus block	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Local direct median nerve block	Procedure: Endoscopic carpal tunnel release under local direct median nerve block; local direct median nerve block is done by surgeon with 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before endoscopic carpal tunnel release(1-portal Agee technique)
Active Comparator: Brachial plexus block	Procedure: Endoscopic carpal tunnel release under brachial plexus block; brachial plexus block under ultrasound-guided by single anesthesiologist with 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before endoscopic carpal tunnel release(1-portal Agee technique)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thammasat University hospital	Khlong Luang	Pathumthani	Thailand	12120

Sponsors and Collaborators

• Thammasat University

Investigators

• Principal Investigator: Chinnakart Boonyasirikool, MD, Department of Orthopaedics, Faculty of Medicine Thammasat University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kittipong Siriboonpipattana, Resident, Thammasat University
• ClinicalTrials.gov Identifier: NCT04453462
• Other Study ID Numbers: MTU-EC-OT-6-227/61
• First Posted: Jul 1, 2020
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kittipong Siriboonpipattana, Resident, Thammasat University: Endoscopic carpal tunnel release
• Additional relevant MeSH terms: Carpal Tunnel Syndrome

Study Results

No Results Posted as of Sep 16, 2020