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NCT01080911 Clinical Trial

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

Pain Clinical Trial

Official title:
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 NCT01080911
Other study ID # Si073/2010
Secondary ID
Status Recruiting
Phase Phase 4
First received March 3, 2010
Last updated September 5, 2011
Start date March 2010
Est. completion date December 2012

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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

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

Intervention

Drug:
• Morphine
spinal morphine 0.05 mg
• Morphine
spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml

Locations
Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital, mahidol University 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 amount of 24 hours morphine 24 hour Yes
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