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

Primary Purpose

Postoperative Pain Relief

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
transdermal fentanyl patch (50 mcg/hour)
Placebo
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Relief focused on measuring transdermal fentanyl patch, postoperative pain,

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Srinagarind hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transdermal fentanyl patch

Placebo

Arm Description

Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery

Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 10, 2012
Last Updated
November 14, 2012
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01726530
Brief Title
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
Official Title
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Relief
Keywords
transdermal fentanyl patch, postoperative pain,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal fentanyl patch
Arm Type
Active Comparator
Arm Description
Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery
Intervention Type
Drug
Intervention Name(s)
transdermal fentanyl patch (50 mcg/hour)
Other Intervention Name(s)
Duragesic
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
morphine consumption
Description
Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
morphine consumption
Description
Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.
Time Frame
48 and 72 hours
Other Pre-specified Outcome Measures:
Title
side effects
Description
Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thepakorn Sathitkarnmanee, MD.
Organizational Affiliation
Khon Kaen University
Official's Role
Study Chair
Facility Information:
Facility Name
Srinagarind hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

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

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