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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

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ClinicalTrials.gov Identifier: NCT00795223
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : September 29, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Post Operative Pain Total Knee Replacement Drug: morphine and bupivacaine Drug: spinal morphine and marcaine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
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
Study Start Date : October 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Global assessment in post operative pain control [ Time Frame: Begining of first enrollment in december 2008 ]

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

Eligibility Criteria

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 Posted: November 21, 2008    Key Record Dates
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