A Randomised controlled trial to compare the efficacy of two types of local anaesthetic blocks in carpal tunnel decompression surgery

Phase 1

• Conditions: Carpal Tunnel Syndrome

• Registration Number: EUCTR2005-003513-32-GB
• Lead Sponsor: South Tees Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-01
• Study Completion: 2006-11-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Adult patients undergoing bilateral carpal tunnel release operations under local anesthesia.
Carpal tunnel syndrome is a disease seen in adults (usually over the age of 35)
We would only include patients with bilateral disease so that we can compare the pain scores on each side
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients unable to consent
2. Patients with rheumatoid arthritis. This is because the operation in these patients may involve additional procedures, eg. excision of synovium. This would bias the pain scores.
3. Patients requiring any procedure in addition to the carpal tunnel release, eg: release of a trigger finger, excision of a swelling in the same hand etc.
4. Patients requiring a general anaesthetic
5. Patients with peripheral neuropathy. These patients may have an altered pain threshold and perception
6. Patients with vascular insufficiency affecting the same hand. They are likely to have more pain due to decreased blood supply to the hand.
7. Patients undergoing re-do carpal tunnel surgery.
8. Patients deemed unfit to undergo the procedure as a day case, including those with congestive cardiac failure, liver disease, impaired respiratory function, epilepsy.
9. Patients with acute porphyrias
10. Pregnant and lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does a median nerve block(injection of a local anaesthetic close to the median nerve) in the carpal tunnel ( A closed space near the wrist) provide better anaesthesia for carpal tunnel release as compared to pure subcutaneous infiltration of the local anaesthetic;<br> Secondary Objective: 1. Is there any difference in the pain experienced during the administration of the local anaesthetic using the two techniques?<br> 2. How long does the effect of the local anesthesia last with the two techniques?<br> ;Primary end point(s): Intra-operative pain, (assessed with a verbal pai scale) in patients undergoing carpal tunnel decompression surgery, using 2 different techniques of administration of the local anaesthetic