EUCTR2011-001510-33-GB
Active, not recruiting
Phase 1
The Efficacy of Continuous Intra-articular Infusion of Local Anaesthetic Agent following Elective Primary Hip Arthroplasty - LIA Hip Study
eeds Teaching Hospitals R and D department0 sites90 target enrollmentAugust 21, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eeds Teaching Hospitals R and D department
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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