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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01726530
Enrollment
50
Registered
2012-11-15
Start date
2011-06-30
Completion date
2012-08-31
Last updated
2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Relief

Keywords

transdermal fentanyl patch, postoperative pain,

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.

Interventions

DRUGtransdermal fentanyl patch (50 mcg/hour)
DRUGPlacebo

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
morphine consumption24 hoursCompare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.

Secondary

MeasureTime frameDescription
morphine consumption48 and 72 hoursCompare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.

Other

MeasureTime frameDescription
side effects72 hoursCompare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026