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Efficacy of Local Direct Median Nerve Block

Primary Purpose

Carpal Tunnel Syndrome, Anesthesia, Local

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Endoscopic carpal tunnel release under local direct median nerve block
Endoscopic carpal tunnel release under brachial plexus block
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Endoscopic carpal tunnel release

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thammasat University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Local direct median nerve block

Brachial plexus block

Arm Description

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

The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
June 26, 2020
Last Updated
April 30, 2023
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT04453462
Brief Title
Efficacy of Local Direct Median Nerve Block
Official Title
Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Anesthesia, Local
Keywords
Endoscopic carpal tunnel release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local direct median nerve block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Brachial plexus block
Arm Type
Active Comparator
Arm Description
The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic carpal tunnel release under local direct median nerve block
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Endoscopic carpal tunnel release under brachial plexus block
Intervention Description
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 Outcome Measure Information:
Title
Intraoperative pain measured as visual analog scale (VAS)
Description
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
Time Frame
Immediate postoperative period
Secondary Outcome Measure Information:
Title
Postoperative pain measured as visual analog scale (VAS)
Description
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.
Time Frame
2 hours, 4 hours, 6 hours and 12 hours postoperative period
Title
Functional outcome of the hand measured as Thai Version Boston Questionnaire
Description
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
Time Frame
2, 4, 12, 24 weeks postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinnakart Boonyasirikool, MD
Organizational Affiliation
Department of Orthopaedics, Faculty of Medicine Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University hospital
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

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Efficacy of Local Direct Median Nerve Block

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