A comparison of the need for opiate pain relief medication after elective hip replacement surgery between patients given either a local anaesthetic infusion to the new joint or a placebo (sterile saline solution) infusion to the new joint.

Phase 1

• Conditions: Pain relief after surgery for patients who have undergone hip replacement due to osteoarthritis or other hip pathology; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-001510-33-GB
• Lead Sponsor: eeds Teaching Hospitals R and D department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-21
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Men and women aged 18-99 • ASA 1-3 • Able to give informed consent • Fit to undergo elective primary total hip arthroplasty
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

• Any patient already taking opioid analgesia or NSAIDs including aspirin • Allergy/sensitivity to local anaesthetics agents • Allergy/sensitivity to NSAIDs • Allergy/sensitivity to adrenaline • Patients taking anti-coagulant medication • Severe liver disease • Severely impaired renal function • Severe heart failure • Active cerebrovascular bleeding • Severe coagulation disorders • Severe asthma or previous bronchospasm with NSAIDs • Porphyria • Active peptic ulcer disease or acute GI bleed • Any patient unable to consent or understand the pump function • Bilateral hip replacements • Pregnancy/lactation (routine pregnancy tests are carried out pre-operatively on all patients of child bearing age) • Any patient already enrolled in another study

Study & Design

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