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

Khon Kaen University

Status: Completed

Conditions: Postoperative Pain Relief

Treatments: Drug: Placebo; Drug: transdermal fentanyl patch (50 mcg/hour)

Study type: Interventional

Funder types: Other

Identifiers

NCT01726530

HE541094

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Transdermal fentanyl patch

Active Comparator group

Description:

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

Treatment:

Drug: transdermal fentanyl patch (50 mcg/hour)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo