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Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty

Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348984
Acronym
TFP
Enrollment
40
Registered
2011-05-06
Start date
2010-04-30
Completion date
2010-12-31
Last updated
2011-05-06

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

Conditions

Postoperative Pain

Keywords

postoperative, pain score, morphine consumption

Brief summary

The purpose of this study is to determine whether transdermal fentanyl patch

Detailed description

Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive. Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain. If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.

Interventions

TFP = transdermal fentanyl patch (50 microgram/hour)

DRUGplacebo patch

group 2 = placebo patch

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
No

Inclusion criteria

* Patients who were scheduled for TKA gave informed consent for inclusion

Exclusion criteria

* ASA class 3-4 * Known allergy to any of the drugs to be used, eg. TFPs ,MO * History of substance or alcohol abuse, and tolerance or dependence on opioids * Can not use PCA * Contraindication for spinal anesthesia

Design outcomes

Primary

MeasureTime frame
intravenous morphine consumption48 hours

Secondary

MeasureTime frame
Pain score48 hours

Countries

Thailand

Outcome results

None listed

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