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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01079754
First Posted: March 3, 2010
Last Update Posted: September 13, 2011
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.
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
  Purpose
This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.

Condition Intervention Phase
Pain Vaginal Hysterectomy Drug: Spinal morphine 0.05 mg Drug: Spinal morphine 0.1 mg 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: The Comparison of 0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty

Resource links provided by NLM:


Further study details as provided by Sirilak Suksompong, Mahidol University:

Primary Outcome Measures:
  • The total amount of morphine that the patient required during the first 24-h postoperative. [ Time Frame: 24 hours ]

Estimated Enrollment: 72
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal morphine 0.05 mg
Patient received spinal morphine 0.05 mg
Drug: Spinal morphine 0.05 mg
Patient received spinal morphine 0.05 mg
Other Name: opioids
Active Comparator: Spinal morphine 0.1 mg
Patient received spinal morphine 0.1 mg
Drug: Spinal morphine 0.1 mg
Patient received spinal morphine 0.1 mg
Other Name: Opioids

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Female ASA physical status 1-3
  • Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
  • Be able to operate patient-controlled analgesia (PCA)

Exclusion Criteria:

  • Allergy to the study drugs
  • History of bleeding tendency
  • Infection at the back
  • Refuse to spinal anesthesia
  • History of CAD or CVA
  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): NCT01079754


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

Locations
Thailand
Faculty of medicine, Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    662891534806    sisuk@mahidol.ac.th   
Principal Investigator: Sirilak Suksompong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, MD Mahidol University
  More Information

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01079754     History of Changes
Other Study ID Numbers: Si 073/2010
First Submitted: March 2, 2010
First Posted: March 3, 2010
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Sirilak Suksompong, Mahidol University:
Spinal morphine 0.05 mg
Spinal morphine

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