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Intrathecal Morphine in Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695045
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University College Hospital Galway
  Purpose
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.

Condition Intervention
Pain, Postoperative Arthroplasty, Replacement, Knee Drug: intra thecal morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • pain [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • nausea and vomiting [ Time Frame: 24 hours ]
  • pruritus [ Time Frame: 24 hours ]
  • sedation [ Time Frame: 24 hours ]

Enrollment: 60
Study Start Date: July 2003
Study Completion Date: April 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients in this group got 100mcg of intrathecal morphine.
Drug: intra thecal morphine
100 mcg intrathecal morphine given once .
Other Name: intraspinal morphine
Experimental: 2
patients in this group got 200 mcg intrathecal morphine
Drug: intra thecal morphine
200 mcg intrathecal morphine given once
Other Name: intra spinal morphine
Experimental: 3
patients in this group given 300 mcg intrathecal morphine.
Drug: intra thecal morphine
300 mcg intrathecal morphine given once
Other Name: intra spinal morphine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients for elective total knee arthroplasty

Exclusion Criteria:

  • No contraindication to spinal
  • No allergy to morphine, rescue analgesia or anti-emesis treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695045


Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Patrick Hassett, Department of Anaesthesia , University College Hospital Galway
ClinicalTrials.gov Identifier: NCT00695045     History of Changes
Other Study ID Numbers: 0001
First Submitted: June 9, 2008
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by University College Hospital Galway:
Pain, Postoperative
Arthroplasty, Replacement, Knee
Morphine
Injections, Intrathecal

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents