Comparison for Pethidine Requirement in Patients Received... | NCT01236495

Studies
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia

NCT01236495

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Mar 13, 2012Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Solitary Mass
Lung Diseases

Interventions

spinal morphine 0.3 mg
spinal morphine 0.2 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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Nov 5, 2010

First Submission Date that Met QC Criteria

Nov 5, 2010

First Posted Date

Nov 8, 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

Mar 11, 2012

Last Update Posted Date

Mar 13, 2012Estimated

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

The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.

Detailed Description

Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spinal morphine 0.2 mg	Experimental	spinal morphine 0.2 mg	Drug: spinal morphine 0.2 mg
spinal morphine 0.3 mg	Active Comparator	spinal morphine 0.3 mg	Drug: spinal morphine 0.3 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spinal morphine 0.3 mg	Drug	spinal morphine 0.3 mg	spinal morphine 0.3 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pethidine requirement	Total pethidine requirement during 48 hours postoperative	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 year and < 70 year
Patient ASA physical status I-III.
Scheduled for thoracotomy with lobectomy.
Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

Known hypersensitivity to morphine or pethidine
History of bleeding tendency.
Known case of infection at the back
Patient refuse for spinal anesthesia
History of cerebrovascular disease.
Scheduled for video-assisted thoracoscopic lobectomy.
Need mechanical ventilatory support during postoperative period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, M.D.	Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided