A comparison of the need for opiate pain relief medication after elective hip replacement surgery between patients given Local Anaesthetic Infiltration to the new joint and then an infusion of either local anaesthetic or placebo around the new joint

Not Applicable

Completed

• Conditions: Primary hip arthroplasty; Musculoskeletal Diseases

• Registration Number: ISRCTN24271997
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-17
• Study Completion: 2013-10-01
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. All patients fit to undergo elective primary hip replacement at Chapel Allerton Hospital
2. Patients who are able to give informed consent
3. American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria

1. Any patient already taking opioid analgesics or non-steroidal anti-inflammatory drugs (NSAID)
2. Allergy/sensitivity to local anaesthetics agents
3. Allergy/sensitivity to NSAIDs
4. Allergy/sensitivity to adrenaline
5. Patients taking anti-coagulant medication
6. Severe liver disease
7. Severely impaired renal function
8. Severe heart failure
9. Active cerebrovascular bleeding
10. Severe coagulation disorders
11. Severe asthma or previous bronchospasm with NSAIDs
12. Porphyria
13. Active peptic ulcer disease or acute gastrointestinal (GI) bleed
14. Any patient unable to consent or understand the pump function
15. Bilateral hip replacements
16. Pregnancy/lactation
17. Patients already enrolled in another study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A 30% reduction in the number of patients requiring opiate analgesia in the 48 hours post-operative period in the treatment group compared to the placebo group. <br>1. Pain is measured using a 10-point Visual Analogue Score (VAS)<br>2. The case report file for each study participant includes data collection on pain scores, opiate and other analgesia requirements and anti-emetic use.

Secondary Outcome Measures

Name	Time	Method
1. Pain scores postoperatively as measured using a 100mm Visual Analogue Score (VAS)<br>2. Time to first mobilisation in hours<br>3. Time to independent mobilisation in hours<br>4. Time to fulfill discharge criteria in days<br>5. Time to hospital discharge in days<br>6. Urinary retention post operatively indicated by requirement for urinary catheter<br>7. Deep vein thrombosis (DVT) / pulmonary embolism (PE) rate at up to outpatient follow up (6-12 weeks post operation)<br>8. Side effects and general medical complications