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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thepakorn Sathitkarnmanee, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01726530
First received: November 10, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • morphine consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.


Secondary Outcome Measures:
  • morphine consumption [ Time Frame: 48 and 72 hours ] [ Designated as safety issue: No ]
    Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.


Other Outcome Measures:
  • side effects [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.


Enrollment: 50
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thepakorn Sathitkarnmanee, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01726530     History of Changes
Other Study ID Numbers: HE541094
Study First Received: November 10, 2012
Last Updated: November 14, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

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

ClinicalTrials.gov processed this record on May 22, 2013