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Clinical Trials/NCT00219921
NCT00219921
Completed
Phase 3

Postoperative Analgesia After Total Hip Replacement

Rijnstate Hospital0 sites120 target enrollmentSeptember 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Total Hip Replacement
Sponsor
Rijnstate Hospital
Enrollment
120
Primary Endpoint
VAS-score for pain at movement and at rest every three hours
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
February 2007
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rijnstate Hospital

Eligibility Criteria

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
  • mental retardation

Outcomes

Primary Outcomes

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 Outcomes

  • 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

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