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

NCT ID: NCT01079754

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Pain Vaginal Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Spinal morphine 0.05 mg

Patient received spinal morphine 0.05 mg

Group Type EXPERIMENTAL

Spinal morphine 0.05 mg

Intervention Type DRUG

Patient received spinal morphine 0.05 mg

Spinal morphine 0.1 mg

Patient received spinal morphine 0.1 mg

Group Type ACTIVE_COMPARATOR

Spinal morphine 0.1 mg

Intervention Type DRUG

Patient received spinal morphine 0.1 mg

Interventions

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Spinal morphine 0.05 mg

Patient received spinal morphine 0.05 mg

Intervention Type DRUG

Spinal morphine 0.1 mg

Patient received spinal morphine 0.1 mg

Intervention Type DRUG

Other Intervention Names

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opioids Opioids

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sirilak Suksompong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of medicine, Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Sirilak Suksompong, MD

Role: CONTACT

6624113256

Facility Contacts

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Sirilak Suksompong, MD

Role: primary

662891534806

Other Identifiers

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Si 073/2010

Identifier Type: -

Identifier Source: org_study_id

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