Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine, Ketorolac and Adrenalin
- Conditions
- Pain, Postoperative
- Sponsor
- Vejle Hospital
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Pain score
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
Investigators
Per Kjaersgaard-Andersen
Per Kjaersgaard-Andersen MD
Vejle Hospital
Eligibility Criteria
Inclusion Criteria
- •Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
- •Willingness and possibility to follow the instructions of the study
- •18 years or older
- •written informed consent and authority after it has been read and understood.
Exclusion Criteria
- •Operation with anterior approach or using navigation
- •Do not understand or speech danish
- •Can not use the pain-score Numerical Rating Scale (NRS)
- •Special indications for Total Hip Replacement
- •Anaesthetized in general anaesthesia where a tube is demanded
- •Daily use of strong opioids, based on the investigators assessment
- •Fertile women
- •ASA-score: 3 and 4
- •Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
- •Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
Arms & Interventions
A
This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.
Intervention: Ropivacaine, Ketorolac and Adrenalin
B
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.
Intervention: Placebo
Outcomes
Primary Outcomes
Pain score
Time Frame: 24 hours
Opioid Consumption
Time Frame: 24 hours
Secondary Outcomes
- Pain score(7 days)
- Opioid consumption(3 days)
- Postoperative Nausea and Vomiting (PONV)(3 days)
- Fatigue(3 days)
- Physical function(2 month)