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Intrathecal Morphine in Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT00695045
First received: June 9, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nausea and vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • pruritus [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • sedation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Patrick Hassett, Department of Anaesthesia , University College Hospital Galway
ClinicalTrials.gov Identifier: NCT00695045     History of Changes
Other Study ID Numbers: 0001
Study First Received: June 9, 2008
Last Updated: June 9, 2008
Health Authority: Ireland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013