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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

The efficacy of continuous intra-articular infusion of local anaesthetic agent following elective primary hip arthroplasty: a single-centre double-blinded randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24271997
Enrollment
70
Registered
2012-01-17
Start date
2011-10-01
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hip arthroplasty Musculoskeletal Diseases Primary hip arthroplasty

Interventions

The total duration of treatment is 48 hours from the time of surgery and the total duration of time in the study is for 6-12 weeks from time of discharge. 1. Attendance at pre-assessment clinic (no
local anaesthetic mixture infiltration (ropivacaine 300mg, ketorolac 30mg and adrenaline 0.5mg) and insertion of pain pump device 6. Treatment group receive a 48h infusion of 0.25% bupivicaine via the

Sponsors

Leeds Teaching Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. 1. Pain is measured using a 10-point Visual Analogue Score (VAS) 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

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

Countries

United Kingdom

Outcome results

None listed

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