Postoperative Analgesia After Total Hip Replacement

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment: 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Sibrand Houtman, MD, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): March 30, 2007
• Last Update Submitted That Met QC Criteria: March 29, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: total hip replacement; pain treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: LTC-349-030905