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

Postoperative Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726530
• Other study ID #: HE541094
• Status: Completed
• Phase: N/A
• First received: November 10, 2012
• Last updated: November 14, 2012
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Relief

Intervention

Drug:
• transdermal fentanyl patch (50 mcg/hour)

• Placebo

Locations

Country	Name	City	State
Thailand	Srinagarind hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	morphine consumption	Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.	24 hours	No
Secondary	morphine consumption	Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.	48 and 72 hours	No