0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine... | NCT01079754

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

NCT01079754

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Sep 13, 2011Estimated

Enrollment

72Estimated

Phase

Phase 4

Conditions

Pain
Vaginal Hysterectomy

Interventions

Spinal morphine 0.05 mg
Spinal morphine 0.1 mg

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Mar 2, 2010

First Submission Date that Met QC Criteria

Mar 2, 2010

First Posted Date

Mar 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2011

Last Update Posted Date

Sep 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spinal morphine 0.05 mg	Experimental	Patient received spinal morphine 0.05 mg	Drug: Spinal morphine 0.05 mg
Spinal morphine 0.1 mg	Active Comparator	Patient received spinal morphine 0.1 mg	Drug: Spinal morphine 0.1 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal morphine 0.05 mg	Drug	Patient received spinal morphine 0.05 mg	Spinal morphine 0.05 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The total amount of morphine that the patient required during the first 24-h postoperative.		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sirilak Suksompong, MD	Contact	6624113256		sisuk@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, Siriraj Hospital	Recruiting	Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000701	Analgesics, Opioid

Ancestor Terms

ID	Term
D009294	Narcotics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided