Transdermal Fentanyl Patch for Postoperative Analgesia Af... | NCT01726530

Studies
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

NCT01726530

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Nov 15, 2012Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Postoperative Pain Relief

Interventions

transdermal fentanyl patch (50 mcg/hour)
Placebo

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

Nov 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

Jun 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Nov 10, 2012

First Submission Date that Met QC Criteria

Nov 14, 2012

First Posted Date

Nov 15, 2012Estimated

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

Nov 14, 2012

Last Update Posted Date

Nov 15, 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

Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually applied but there is no perfect choice. It depends on physician's skill and situation. The best regimen is patient-controlled analgesia, but it requires an expensive equipment. Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.

Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 72 hours.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transdermal fentanyl patch	Active Comparator	Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery	Drug: transdermal fentanyl patch (50 mcg/hour)
Placebo	Placebo Comparator	Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transdermal fentanyl patch (50 mcg/hour)	Drug		Transdermal fentanyl patch	Duragesic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morphine consumption	Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
morphine consumption	Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.	48 and 72 hours

Other Outcomes

Measure	Description	Time Frame
side effects	Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.	72 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age =>18 years
scheduled for abdominal surgery

Exclusion Criteria:

ASA class > 3
Known allergy to fentanyl or morphine
History of substance or alcohol abuse, and tolerance or dependence on opioids
Combined epidural block
Can't use PCA, abnormal renal / liver function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Thepakorn Sathitkarnmanee, MD.	Khon Kaen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Srinagarind hospital		Khon Kaen	Changwat Khon Kaen	40002	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided