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Postoperative Analgesia After Total Hip Replacement

NCT ID: NCT00219921

Last Updated: 2007-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Total Hip Replacement

Keywords

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total hip replacement pain treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intrathecal morphine at surgery, 0.1mg and placebo

Intervention Type DRUG

Patient Controlled Analgesia with iv morphine and placebo

Intervention Type DRUG

intrathecal morphine AND patient controlled analgesia with iv morphine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Sibrand Houtman, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Other Identifiers

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LTC-349-030905

Identifier Type: -

Identifier Source: org_study_id