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

Phase 4

• Conditions: Pain; Vaginal Hysterectomy
• Interventions: Drug: Spinal morphine 0.05 mg; Drug: Spinal morphine 0.1 mg

• Registration Number: NCT01079754
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-10
• Last Update Posted: 2011-09-13
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal morphine 0.05 mg	Spinal morphine 0.05 mg	Patient received spinal morphine 0.05 mg
Spinal morphine 0.1 mg	Spinal morphine 0.1 mg	Patient received spinal morphine 0.1 mg

Primary Outcome Measures

Name	Time	Method
The total amount of morphine that the patient required during the first 24-h postoperative.	24 hours

Trial Locations

Locations (1)

Faculty of medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand