Intrathecal Morphine in Knee Arthroplasty

NCT ID: NCT00695045

Last Updated: 2008-06-11

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-04-30

Brief Summary

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This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.

Detailed Description

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Conditions

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Pain, Postoperative Arthroplasty, Replacement, Knee

Keywords

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Pain, Postoperative Arthroplasty, Replacement, Knee Morphine Injections, Intrathecal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

patients in this group got 100mcg of intrathecal morphine.

Group Type EXPERIMENTAL

intra thecal morphine

Intervention Type DRUG

100 mcg intrathecal morphine given once .

2

patients in this group got 200 mcg intrathecal morphine

Group Type EXPERIMENTAL

intra thecal morphine

Intervention Type DRUG

200 mcg intrathecal morphine given once

3

patients in this group given 300 mcg intrathecal morphine.

Group Type EXPERIMENTAL

intra thecal morphine

Intervention Type DRUG

300 mcg intrathecal morphine given once

Interventions

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intra thecal morphine

100 mcg intrathecal morphine given once .

Intervention Type DRUG

intra thecal morphine

200 mcg intrathecal morphine given once

Intervention Type DRUG

intra thecal morphine

300 mcg intrathecal morphine given once

Intervention Type DRUG

Other Intervention Names

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intraspinal morphine intra spinal morphine intra spinal morphine

Eligibility Criteria

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Inclusion Criteria

* Patients for elective total knee arthroplasty

Exclusion Criteria

* No contraindication to spinal
* No allergy to morphine, rescue analgesia or anti-emesis treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital Galway

OTHER

Sponsor Role lead

Responsible Party

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Department of Anaesthesia , University College Hospital Galway

Principal Investigators

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Patrick D Hassett, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, UCHG

John Laffey, MD

Role: STUDY_CHAIR

Department of Anaesthesia,UCHG

Brian Kinirons, MD

Role: STUDY_DIRECTOR

Dept of Anaesthesia , UCHG

References

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Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.

Reference Type DERIVED
PMID: 18816386 (View on PubMed)

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id