Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 10, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedNovember 15, 2012
November 1, 2012
4 months
November 10, 2012
November 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
morphine consumption
Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.
24 hours
Secondary Outcomes (1)
morphine consumption
48 and 72 hours
Other Outcomes (1)
side effects
72 hours
Study Arms (2)
Transdermal fentanyl patch
ACTIVE COMPARATORTransdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery
Placebo
PLACEBO COMPARATORPlacebo patch was attached to the patient's chest wall at 10 pm the day before surgery
Interventions
Eligibility Criteria
You may qualify if:
- age =\>18 years
- scheduled for abdominal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Srinagarind hospital
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thepakorn Sathitkarnmanee, MD.
Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 10, 2012
First Posted
November 15, 2012
Study Start
June 1, 2011
Primary Completion
October 1, 2011
Study Completion
August 1, 2012
Last Updated
November 15, 2012
Record last verified: 2012-11