Skip to content

Efficacy of Local Direct Median Nerve Block

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04453462
Enrollment
50
Registered
2020-07-01
Start date
2018-05-01
Completion date
2021-09-01
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Carpal Tunnel Syndrome

Keywords

Endoscopic carpal tunnel release

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)

Interventions

PROCEDUREEndoscopic 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)

PROCEDUREEndoscopic 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)

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative pain measured as visual analog scale (VAS)Immediate postoperative periodVisual 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

MeasureTime frameDescription
Postoperative pain measured as visual analog scale (VAS)2 hours, 4 hours, 6 hours and 12 hours postoperative periodVisual 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 Questionnaire2, 4, 12, 24 weeks postoperative periodThere are 2 parts of Thai Version Boston Questionnaire 1. Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome) 2. 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026