Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
|ClinicalTrials.gov Identifier: NCT01726530|
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Relief||Drug: transdermal fentanyl patch (50 mcg/hour) Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||August 2012|
Active Comparator: Transdermal fentanyl patch
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)
Other Name: Duragesic
Placebo Comparator: Placebo
Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery
- morphine consumption [ Time Frame: 24 hours ]Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.
- morphine consumption [ Time Frame: 48 and 72 hours ]Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.
- side effects [ Time Frame: 72 hours ]Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726530
|Khon Kaen, Thailand, 40002|
|Study Chair:||Thepakorn Sathitkarnmanee, MD.||Khon Kaen University|