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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01079754
• Other study ID #: Si 073/2010
• Status: Recruiting
• Phase: Phase 4
• First received: March 2, 2010
• Last updated: September 10, 2011
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2011
• Source: Mahidol University
• Contact: Sirilak Suksompong, MD
• Phone: 6624113256
• Email: sisuk[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Vaginal Hysterectomy

Intervention

Drug:
• Spinal morphine 0.05 mg
Patient received spinal morphine 0.05 mg
• Spinal morphine 0.1 mg
Patient received spinal morphine 0.1 mg

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of morphine that the patient required during the first 24-h postoperative.		24 hours	Yes