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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003513-32-GB
Enrollment
20
Registered
2005-08-01
Start date
2005-08-31
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Carpal Tunnel Syndrome

Interventions

Trade Name: Lignocaine 2% with preservative Product Name: Lignocaine 2% with preservative Pharmaceutical Form: Injection*

Sponsors

South Tees Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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; Secondary Objective: 1. Is there any difference in the pain experienced during the administration of the local anaesthetic using the two techniques? 2. How long does the effect of the local anesthesia last with the two techniques? ;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

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026