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Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty (TFP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
transdermal fentanyl patch
placebo patch
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative, pain score, morphine consumption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group 1

group 2

Arm Description

group 1 = transdermal fentanyl patch

placebo patch

Outcomes

Primary Outcome Measures

intravenous morphine consumption

Secondary Outcome Measures

Pain score

Full Information

First Posted
May 4, 2011
Last Updated
May 5, 2011
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01348984
Brief Title
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty
Acronym
TFP
Official Title
Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative, pain score, morphine consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
group 1 = transdermal fentanyl patch
Arm Title
group 2
Arm Type
Placebo Comparator
Arm Description
placebo patch
Intervention Type
Drug
Intervention Name(s)
transdermal fentanyl patch
Other Intervention Name(s)
Duragesic
Intervention Description
TFP = transdermal fentanyl patch (50 microgram/hour)
Intervention Type
Drug
Intervention Name(s)
placebo patch
Other Intervention Name(s)
Duragesic
Intervention Description
group 2 = placebo patch
Primary Outcome Measure Information:
Title
intravenous morphine consumption
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain score
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thepakorn Sathitkarnmanee, MD
Organizational Affiliation
Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

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

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