EUCTR2005-003513-32-GB
Active, not recruiting
Phase 1
A Randomised controlled trial to compare the efficacy of two types of local anaesthetic blocks in carpal tunnel decompression surgery
South Tees Hospitals NHS Trust0 sites20 target enrollmentAugust 1, 2005
ConditionsCarpal Tunnel Syndrome
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Carpal Tunnel Syndrome
- Sponsor
- South Tees Hospitals NHS Trust
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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