A randomised controlled trial of fentanyl versus morphine following lower limb arthroplasty - OTFC/TF TRIA
Phase 1
- Conditions
- Patients with significant pain following hip or knee arthroplasty
- Registration Number
- EUCTR2006-001808-37-GB
- Lead Sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria
Patients with a visual analogue pain score on movement greater than 6/10 on day 1 post operation.
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. Where the trial drugs are contraindicated.
2. If the patient is unable to comply with the post operative physiotherapy regime because of pathology other than in the operated joint.
3. Where patient refuses or is unable to give consent.
4. If the indication for hip or knee replacement is trauma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the efficacy of fentanyl analgesia following hip or knee arthroplasty by comparison with i.v.morphine. A fast acting Fentanyl lozenge will be used for breakthrough or movement pain. A Fentanyl patch will provide a background dose. The morphine will be administered intra-venously by a patient controlled analgesia (PCA) pump.;Secondary Objective: To establish the tolerability safety and cost effectiveness of fentanyl analgesia, in lozenge and patch form following lower limb arthroplasty. Again this will be in comparison with morphine given by PCA. The usefulness of fentanyl patches following discharge will also be evaluated, in comparison with simple oral analgesia.;Primary end point(s): A difference in the visual analogue pain scores with movement between the fentanyl and Morphine arms of the trial.
- Secondary Outcome Measures
Name Time Method