Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty
- Conditions
- Postoperative Pain
- Interventions
- Drug: placebo patch
- Registration Number
- NCT01348984
- Lead Sponsor
- Khon Kaen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patients who were scheduled for TKA gave informed consent for inclusion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1 transdermal fentanyl patch group 1 = transdermal fentanyl patch group 2 placebo patch placebo patch
- Primary Outcome Measures
Name Time Method intravenous morphine consumption 48 hours
- Secondary Outcome Measures
Name Time Method Pain score 48 hours
Trial Locations
- Locations (1)
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
🇹🇭Khon Kaen, Thailand