Efficacy of Local Direct Median Nerve Block

NCT ID: NCT04453462

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-09-01

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)

Conditions

Carpal Tunnel Syndrome; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local direct median nerve block

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

Group Type: ACTIVE_COMPARATOR

Endoscopic carpal tunnel release under local direct median nerve block

Intervention Type: 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)

Brachial plexus block

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

Group Type: ACTIVE_COMPARATOR

Endoscopic carpal tunnel release under brachial plexus block

Intervention Type: 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)

Interventions

Endoscopic 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)

Intervention Type: PROCEDURE

Endoscopic 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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Kittipong Siriboonpipattana

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chinnakart Boonyasirikool, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Faculty of Medicine Thammasat University

Locations

Thammasat University hospital

Khlong Luang, Changwat Pathum Thani, Thailand

Countries

Thailand

Other Identifiers

MTU-EC-OT-6-227/61

Identifier Type: -

Identifier Source: org_study_id