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

September 5, 2011 updated by: Sirilak Suksompong, Mahidol University

0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine, Siriraj Hospital, Mahidol University
        • Principal Investigator:
          • Sirilak Suksompong, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • opioid
Drug: Morphine
spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml
Other Names:
  • 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 0.05 mg
Other Names:
  • opioid
Drug: Morphine
spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml
Other Names:
  • Opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the amount of 24 hours morphine
Time Frame: 24 hour
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Sirilak Suksompong, MD, Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 5, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si073/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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