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Intrathecal Morphine in Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00695045
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:
University College Hospital Galway

Brief Summary:
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 or disease Intervention/treatment
Pain, Postoperative Arthroplasty, Replacement, Knee Drug: intra thecal morphine

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : July 2003
Primary Completion Date : January 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. pain [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. nausea and vomiting [ Time Frame: 24 hours ]
  2. pruritus [ Time Frame: 24 hours ]
  3. sedation [ Time Frame: 24 hours ]


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.

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

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 Posted: June 11, 2008    Key Record Dates
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