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

Not Applicable

Completed

• Conditions: Postoperative Pain Relief
• Interventions: Drug: transdermal fentanyl patch (50 mcg/hour); Drug: Placebo

• Registration Number: NCT01726530
• Lead Sponsor: Khon Kaen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2012-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-10
• Study First Submitted QC: 2012-11-14
• Last Update Submitted: 2012-11-14
• Study First Posted: 2012-11-15
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal fentanyl patch	transdermal fentanyl patch (50 mcg/hour)	Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery
Placebo	Placebo	Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
morphine consumption	48 and 72 hours	Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.

Trial Locations

Locations (1)

Srinagarind hospital; 🇹🇭 Khon Kaen, Thailand