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

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ClinicalTrials.gov Identifier: NCT01080911
Recruitment Status : Unknown
Verified September 2011 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Recruiting
First Posted : March 4, 2010
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

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
Pain Drug: Morphine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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 Name: 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 Name: Opioid




Primary Outcome Measures :
  1. the amount of 24 hours morphine [ Time Frame: 24 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01080911


Contacts
Contact: Sirilak Suksompong, MD 6624113256 sisuk@mahidol.ac.th

Locations
Thailand
Faculty of Medicine, Siriraj Hospital, mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    6604113256    sisuk@mahidol.ac.th   
Principal Investigator: Sirilak Suksompong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, MD Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01080911     History of Changes
Other Study ID Numbers: Si073/2010
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Sirilak Suksompong, Mahidol University:
Spinal morphine
Vaginal hysterectomy

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents