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

This study is currently recruiting participants.
Verified September 2011 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier:
NCT01079754
First received: March 2, 2010
Last updated: September 10, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Mahidol University:

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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01079754     History of Changes
Other Study ID Numbers: Si 073/2010
Study First Received: March 2, 2010
Last Updated: September 10, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Spinal morphine 0.05 mg
Spinal morphine

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

ClinicalTrials.gov processed this record on May 23, 2013