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
About this trial
This is an interventional treatment trial for Postoperative Pain Relief focused on measuring transdermal fentanyl patch, postoperative pain,
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
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
NCT ID
NCT01726530
First Posted
November 10, 2012
Last Updated
November 14, 2012
Sponsor
Khon Kaen University
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
Learn more about this trial
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
We'll reach out to this number within 24 hrs