Intrathecal Morphine in Knee Arthroplasty - Full Text View

Sponsor:	University College Hospital Galway
Information provided by:	University College Hospital Galway
ClinicalTrials.gov Identifier:	NCT00695045

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Knee Replacement Nausea and Vomiting

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
1: Experimental patients in this group got 100mcg of intrathecal morphine.	Drug: intra thecal morphine 100 mcg intrathecal morphine given once .
2: Experimental patients in this group got 200 mcg intrathecal morphine	Drug: intra thecal morphine 200 mcg intrathecal morphine given once
3: Experimental patients in this group given 300 mcg intrathecal morphine.	Drug: intra thecal morphine 300 mcg intrathecal morphine given once

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:	Department of Anaesthesia , University College Hospital Galway ( Dr Patrick Hassett )
Study ID Numbers:	0001
Study First Received:	June 9, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00695045 History of Changes
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:

Morphine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 05, 2009