Study of Transdermal Fentanyl Patch to Treat Postoperativ... | NCT01348984

Studies
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty

NCT01348984

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

May 6, 2011Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

transdermal fentanyl patch
placebo patch

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

Feb 2010

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

Apr 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

May 4, 2011

First Submission Date that Met QC Criteria

May 5, 2011

First Posted Date

May 6, 2011Estimated

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

May 5, 2011

Last Update Posted Date

May 6, 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

The purpose of this study is to determine whether transdermal fentanyl patch

Detailed Description

Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive.

Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.

If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.

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
group 1	Active Comparator	group 1 = transdermal fentanyl patch	Drug: transdermal fentanyl patch
group 2	Placebo Comparator	placebo patch	Drug: placebo patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transdermal fentanyl patch	Drug	TFP = transdermal fentanyl patch (50 microgram/hour)	group 1

Measure	Description	Time Frame
intravenous morphine consumption		48 hours

Measure	Description	Time Frame
Pain score		48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who were scheduled for TKA gave informed consent for inclusion

Exclusion Criteria:

ASA class 3-4
Known allergy to any of the drugs to be used, eg. TFPs ,MO
History of substance or alcohol abuse, and tolerance or dependence on opioids
Can not use PCA
Contraindication for spinal anesthesia

Accepts Healthy Volunteers

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University		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