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Postoperative Analgesia After Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00219921
First received: September 13, 2005
Last updated: March 29, 2007
Last verified: March 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Postoperative Analgesia After Total Hip Replacement

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

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

No publications provided

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

Keywords provided by Rijnstate Hospital:
total hip replacement
pain treatment

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013