Efficacy of Local Direct Median Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Anesthesia, Local
• Intervention / Treatment: Procedure: Endoscopic carpal tunnel release under local direct median nerve block; Procedure: Endoscopic carpal tunnel release under brachial plexus block

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kittipong Siriboonpipattana, MD; Phone Number: +66894241063; Email: 025bee.r404@gmail.com

Study Locations

• Thailand
  • Pathumthani
    • Khlong Luang, Pathumthani, Thailand, 12120
      • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local direct median nerve block; The local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve	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)
Active Comparator: Brachial plexus block; The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopic carpal tunnel release
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: MTU-EC-OT-6-227/61

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No