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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01726530
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Postoperative Pain Relief Drug: transdermal fentanyl patch (50 mcg/hour) Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
Study Start Date : June 2011
Primary Completion Date : October 2011
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. morphine consumption [ Time Frame: 24 hours ]
    Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726530


Locations
Thailand
Srinagarind hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Study Chair: Thepakorn Sathitkarnmanee, MD. Khon Kaen University
More Information

Responsible Party: Thepakorn Sathitkarnmanee, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01726530     History of Changes
Other Study ID Numbers: HE541094
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Thepakorn Sathitkarnmanee, Khon Kaen University:
transdermal fentanyl patch, postoperative pain,

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics