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Clinical Trials/NCT01726530
NCT01726530
Completed
Not Applicable

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

Khon Kaen University1 site in 1 country50 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
transdermal fentanyl patch (50 mcg/hour)
Conditions
Postoperative Pain Relief
Sponsor
Khon Kaen University
Enrollment
50
Locations
1
Primary Endpoint
morphine consumption
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thepakorn Sathitkarnmanee

Associate Professor

Khon Kaen University

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

Arms & Interventions

Transdermal fentanyl patch

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

Intervention: transdermal fentanyl patch (50 mcg/hour)

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

morphine consumption

Time Frame: 24 hours

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

Secondary Outcomes

  • morphine consumption(48 and 72 hours)

Study Sites (1)

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