A Phase 3 interventional study of Intrathecal morphine at surgery, 0.1mg and placebo and Patient Controlled Analgesia with iv morphine and placebo in Total Hip Replacement, sponsored by Rijnstate Hospital. Completed. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-03-30.
Sponsored by Rijnstate Hospital · Phase 3, Interventional, and Treatment
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.
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.
Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
No study locations are listed for this record.
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital