Intrathecal Morphine in Knee Arthroplasty
Primary Purpose
Pain, Postoperative, Arthroplasty, Replacement, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intra thecal morphine
intra thecal morphine
intra thecal morphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
patients in this group got 100mcg of intrathecal morphine.
patients in this group got 200 mcg intrathecal morphine
patients in this group given 300 mcg intrathecal morphine.
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
nausea and vomiting
pruritus
sedation
Full Information
NCT ID
NCT00695045
First Posted
June 9, 2008
Last Updated
June 9, 2008
Sponsor
University College Hospital Galway
1. Study Identification
Unique Protocol Identification Number
NCT00695045
Brief Title
Intrathecal Morphine in Knee Arthroplasty
Official Title
Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University College Hospital Galway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Arthroplasty, Replacement, Knee
Keywords
Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
patients in this group got 100mcg of intrathecal morphine.
Arm Title
2
Arm Type
Experimental
Arm Description
patients in this group got 200 mcg intrathecal morphine
Arm Title
3
Arm Type
Experimental
Arm Description
patients in this group given 300 mcg intrathecal morphine.
Intervention Type
Drug
Intervention Name(s)
intra thecal morphine
Other Intervention Name(s)
intraspinal morphine
Intervention Description
100 mcg intrathecal morphine given once .
Intervention Type
Drug
Intervention Name(s)
intra thecal morphine
Other Intervention Name(s)
intra spinal morphine
Intervention Description
200 mcg intrathecal morphine given once
Intervention Type
Drug
Intervention Name(s)
intra thecal morphine
Other Intervention Name(s)
intra spinal morphine
Intervention Description
300 mcg intrathecal morphine given once
Primary Outcome Measure Information:
Title
pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
nausea and vomiting
Time Frame
24 hours
Title
pruritus
Time Frame
24 hours
Title
sedation
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick D Hassett, MD
Organizational Affiliation
Department of Anaesthesia, UCHG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Laffey, MD
Organizational Affiliation
Department of Anaesthesia,UCHG
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Brian Kinirons, MD
Organizational Affiliation
Dept of Anaesthesia , UCHG
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18816386
Citation
Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
Results Reference
derived
Learn more about this trial
Intrathecal Morphine in Knee Arthroplasty
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