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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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT00795223
Collaborator
Siriraj Hospital (Other)
160
Enrollment
1
Location
4
Arms
7
Duration (Months)
23
Patients Per Site Per Month

Study Details

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
  • Drug: morphine and bupivacaine
  • Drug: spinal morphine and marcaine
  • Drug: morphine and bupivacaine
  • Drug: morphine and bupivacaine
 Phase 4

Study Design

Study Type:
Interventional
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 :
Oct 1, 2008
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Global assessment in post operative pain control [Begining of first enrollment in december 2008]

    Secondary Outcome Measures

    1. Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS [first enrollment in December 2008]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Siriraj Hospital Bangkok Bangkoknoi Thailand 10700

    Sponsors and Collaborators

    • Mahidol University
    • Siriraj Hospital

    Investigators

    • Principal Investigator: Thitima Chinachoti, MD, Siriraj Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00795223
    Other Study ID Numbers:
    • 461/2551(EC1)
    • Grant by the siriraj Hospital
    First Posted:
    Nov 21, 2008
    Last Update Posted:
    Sep 29, 2009
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Pain, Postoperative
    Morphine
    Bupivacaine

    Study Results

    No Results Posted as of Sep 29, 2009