Postoperative Analgesia After Total Hip Replacement - Full Text View

Sponsored by:	Rijnstate Hospital
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00219921

Purpose

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.

Condition	Intervention	Phase
Total Hip Replacement	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	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Postoperative Analgesia After Total Hip Replacement

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	120
Study Start Date:	September 2005
Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219921

Sponsors and Collaborators

Rijnstate Hospital

Investigators

Principal Investigator:

Sibrand Houtman, MD

Rijnstate Hospital

More Information

Study ID Numbers:	LTC-349-030905
Study First Received:	September 13, 2005
Last Updated:	March 29, 2007
ClinicalTrials.gov Identifier:	NCT00219921
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:

total hip replacement
pain treatment

Study placed in the following topic categories:

Morphine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009