A randomised controlled trial of fentanyl versus morphine following lower limb arthroplasty - OTFC/TF TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001808-37-GB

Enrollment

204

Registered

2006-09-20

Start date

2006-09-13

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

Patients with significant pain following hip or knee arthroplasty

Interventions

Pharmaceutical Form: Lozenge Pharmaceutical Form: Transdermal patch

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

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