Efficacy of Local Direct Median Nerve Block

NCT04453462 | Completed DMC

• 1 other identifier: MTU-EC-OT-6-227/61
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Anesthesia, Local

Keywords

Endoscopic carpal tunnel release

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain measured as visual analog scale (VAS)

  2 hours, 4 hours, 6 hours and 12 hours postoperative period

• Functional outcome of the hand measured as Thai Version Boston Questionnaire

  2, 4, 12, 24 weeks postoperative period

Study Arms (2)

Local direct median nerve block

ACTIVE COMPARATOR

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

Brachial plexus block

ACTIVE COMPARATOR

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

Interventions

Endoscopic carpal tunnel release under local direct median nerve block PROCEDURE

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)

Local direct median nerve block

Endoscopic carpal tunnel release under brachial plexus block PROCEDURE

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)

Brachial plexus block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Chinnakart Boonyasirikool, MD

  Department of Orthopaedics, Faculty of Medicine Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: May 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

TH (1)