Postoperative Analgesia After Total Hip Replacement

Condition(s) targeted: Total Hip Replacement

Intervention: 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Rijnstate Hospital

Official(s) and/or principal investigator(s):
Sibrand Houtman, MD, Principal Investigator, Affiliation: Rijnstate Hospital

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.

Official title: Postoperative Analgesia After Total Hip Replacement

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

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:

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

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.

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

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 dementia mental retardation

Starting date: September 2005
Ending date: February 2007
Last updated: March 29, 2007