Postoperative Analgesia After Total Hip Replacement

Total Hip Replacement Clinical Trial

Official title:

Postoperative Analgesia After Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219921
• Other study ID #: LTC-349-030905
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 29, 2007
• Start date: September 2005
• Est. completion date: February 2007

Study information

• Verified date: March 2007
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Drug:
• Intrathecal morphine at surgery, 0.1mg and placebo

• Patient Controlled Analgesia with iv morphine and placebo

• intrathecal morphine AND patient controlled analgesia with iv morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS-score for pain at movement and at rest every three hours
Primary	PCA-bolus-sum every three-hour period
Primary	Morphine-IM rescue dose every three-hour period
Secondary	patient satisfaction each 24 hours
Secondary	iv-morphine dose needed to attain VAS-score under 40 mm
Secondary	PONV every three hours
Secondary	urine retention every three hours
Secondary	itching every three hours
Secondary	decrease in saturation every three hours
Secondary	quality of physical training