Intrathecal Morphine in Knee Arthroplasty

June 9, 2008 updated by: University College Hospital Galway

Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients for elective total knee arthroplasty

Exclusion Criteria:

  • No contraindication to spinal
  • No allergy to morphine, rescue analgesia or anti-emesis treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
patients in this group got 100mcg of intrathecal morphine.
Drug: intra thecal morphine
100 mcg intrathecal morphine given once .
Other Names:
  • intraspinal morphine
Drug: intra thecal morphine
200 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine
Drug: intra thecal morphine
300 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine
EXPERIMENTAL: 2
patients in this group got 200 mcg intrathecal morphine
Drug: intra thecal morphine
100 mcg intrathecal morphine given once .
Other Names:
  • intraspinal morphine
Drug: intra thecal morphine
200 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine
Drug: intra thecal morphine
300 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine
EXPERIMENTAL: 3
patients in this group given 300 mcg intrathecal morphine.
Drug: intra thecal morphine
100 mcg intrathecal morphine given once .
Other Names:
  • intraspinal morphine
Drug: intra thecal morphine
200 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine
Drug: intra thecal morphine
300 mcg intrathecal morphine given once
Other Names:
  • intra spinal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
nausea and vomiting
Time Frame: 24 hours
24 hours
pruritus
Time Frame: 24 hours
24 hours
sedation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Hospital Galway

Investigators

  • Principal Investigator: Patrick D Hassett, MD, Department of Anaesthesia, UCHG
  • Study Chair: John Laffey, MD, Department of Anaesthesia,UCHG
  • Study Director: Brian Kinirons, MD, Dept of Anaesthesia , UCHG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (ESTIMATE)

June 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Cancer Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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