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

September 13, 2005
March 29, 2007
September 2005
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00219921 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Postoperative Analgesia After Total Hip Replacement
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2007
Not Provided

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00219921
LTC-349-030905
Not Provided
Not Provided
Rijnstate Hospital
Not Provided
Principal Investigator: Sibrand Houtman, MD Rijnstate Hospital
Rijnstate Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP