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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795223
First Posted: November 21, 2008
Last Update Posted: September 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University
  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 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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 ]

Secondary Outcome Measures:
  • Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS [ Time Frame: first enrollment in December 2008 ]

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
Active Comparator: 1
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
Other Name: marcaine
Active Comparator: 2
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
Other Name: marcaine
Active Comparator: 3
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
Other Name: marcaine
Active Comparator: 4
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
Other Name: marcaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795223


Locations
Thailand
Siriraj Hospital
Bangkok, Bangkoknoi, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
Principal Investigator: Thitima Chinachoti, MD Siriraj Hospital
  More Information

Responsible Party: Thitima Chinachoti, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00795223     History of Changes
Other Study ID Numbers: 461/2551(EC1)
Grant by the siriraj Hospital
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: September 29, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics