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0.05 mg Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01080911
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
33.1
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare the effect of spinal morphine between the dose 0.05 mg and 0.1 mg on the amount of morphine during the first 24 hours postoperative.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: spinal morphine 0.05 mg

spinal morphine 0.05 mg plus 0.5% heavy marcaine 3.5 ml

Drug: Morphine
spinal morphine 0.05 mg
Other Names:
  • opioid

    		•
    Active Comparator: spinal morphine 0.1 mg

    spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml

    Drug: Morphine
    spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml
    Other Names:
  • Opioid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the amount of 24 hours morphine [24 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female ASA 1-3

    • Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty

    • Can operate PCA device

    Exclusion Criteria:

    • History of allergy to the study drugs

    • History of bleeding tendency

    • History of infection at the back

    • Patient refuse to have spinal anesthesia

    • History of CAD or CVD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Siriraj Hospital, mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Sirilak Suksompong, MD, Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sirilak Suksompong, Associate Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01080911
    Other Study ID Numbers:
    • Si073/2010
    First Posted:
    Mar 4, 2010
    Last Update Posted:
    Sep 7, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Sirilak Suksompong, Associate Professor, Mahidol University
    Spinal morphine
    Vaginal hysterectomy
    Additional relevant MeSH terms:
    Morphine
    Analgesics, Opioid

    Study Results

    No Results Posted as of Sep 7, 2011