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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Relief
• Intervention / Treatment: Drug: Placebo; Drug: transdermal fentanyl patch (50 mcg/hour)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Duragesic
PLACEBO_COMPARATOR: Placebo; Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.	48 and 72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.	72 hours

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Study Chair: Thepakorn Sathitkarnmanee, MD., Khon Kaen University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: November 10, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (ESTIMATE): November 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 14, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: transdermal fentanyl patch, postoperative pain,
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: HE541094