Clinical trial NCT04453462: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Anesthesia, Local
Keywords: Endoscopic carpal tunnel release
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative pain measured as visual analog scale (VAS)
timeFrame: Immediate postoperative period
Secondary outcomes:
measure: Postoperative pain measured as visual analog scale (VAS)
timeFrame: 2 hours, 4 hours, 6 hours and 12 hours postoperative period
measure: Functional outcome of the hand measured as Thai Version Boston Questionnaire
timeFrame: 2, 4, 12, 24 weeks postoperative period
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University hospital
state: Pathumthani
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Thammasat University
name: Chinnakart Boonyasirikool, MD
role: PRINCIPAL_INVESTIGATOR
References: