Postoperative Analgesia After Total Hip Replacement

Study Overview
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Brief Summary
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There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

Detailed Description
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This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized. VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.

Official Title
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Postoperative Analgesia After Total Hip Replacement

Conditions
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Total Hip Replacement

Intervention / Treatment
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* Drug: Intrathecal morphine at surgery, 0.1mg and placebo
* Drug: Patient Controlled Analgesia with iv morphine and placebo
* Drug: intrathecal morphine AND patient controlled analgesia with iv morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower Exclusion Criteria: Not able to speak dutch communication problems dementia mental retardation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intrathecal morphine at surgery, 0.1mg and placebo|nan|
|Drug: Patient Controlled Analgesia with iv morphine and placebo|nan|
|Drug: intrathecal morphine AND patient controlled analgesia with iv morphine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-score for pain at movement and at rest every three hours |  |  | 
| PCA-bolus-sum every three-hour period |  |  | 
| Morphine-IM rescue dose every three-hour period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction each 24 hours |  |  | 
| iv-morphine dose needed to attain VAS-score under 40 mm |  |  | 
| PONV every three hours |  |  | 
| urine retention every three hours |  |  | 
| itching every three hours |  |  | 
| decrease in saturation every three hours |  |  | 
| quality of physical training |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip replacement, pain treatment