Intrathecal Morphine in Knee Arthroplasty - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2008

Last Updated Date

June 9, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Intrathecal Morphine in Knee Arthroplasty

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pain, Postoperative
Arthroplasty, Replacement, Knee

Intervention ^ICMJE

Drug: intra thecal morphine

Study Arms / Comparison Groups

Experimental: patients in this group got 100mcg of intrathecal morphine.
Experimental: patients in this group got 200 mcg intrathecal morphine
Experimental: patients in this group given 300 mcg intrathecal morphine.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients for elective total knee arthroplasty

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00695045

Responsible Party

Dr Patrick Hassett, Department of Anaesthesia , University College Hospital Galway

Study ID Numbers ^ICMJE

0001

Study Sponsor ^ICMJE

University College Hospital Galway

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University College Hospital Galway

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP