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Completed

NCT Number: NCT04453462

Efficacy of Local Direct Median Nerve Block

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.

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Key information

Conditions

Carpal Tunnel Syndrome Anesthesia, Local Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thammasat University hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

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)

Primary outcomes

  1. Intraoperative pain measured as visual analog scale (VAS)

    Time frame: 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 outcomes

  1. Postoperative pain measured as visual analog scale (VAS)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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