Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA - Full Text View

Sponsor:	Mahidol University
Collaborator:	Siriraj Hospital
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00795223

Purpose

Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block

Condition	Intervention	Phase
Post Operative Pain Total Knee Replacement	Drug: morphine and bupivacaine Drug: spinal morphine and marcaine Drug: morphine and bupivacaine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Global assessment in post operative pain control [ Time Frame: Begining of first enrollment in december 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS [ Time Frame: first enrollment in December 2008 ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	October 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine	Drug: morphine and bupivacaine 0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
2: Active Comparator Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine	Drug: spinal morphine and marcaine 0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
3: Active Comparator Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine	Drug: morphine and bupivacaine 0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
4: Active Comparator Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine	Drug: morphine and bupivacaine 0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation

Exclusion Criteria:

patient at risk in usage COX-2 for post operative pain control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795223

Locations

Thailand, Bangkoknoi
Siriraj Hospital
Bangkok, Bangkoknoi, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Siriraj Hospital

Investigators

Principal Investigator:

Thitima Chinachoti, MD

Siriraj Hospital

More Information

No publications provided

Responsible Party:	Siriraj Hospital ( Thitima Chinachoti )
Study ID Numbers:	461/2551(EC1), Grant by the siriraj Hospital
Study First Received:	November 20, 2008
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00795223 History of Changes
Health Authority:	Thailand: Ethical Committee

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010