Comparison of Patient-controlled Analgesia With Background Opioid Versus Non-opioid Infusion for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: a Randomized, Non-inferiority Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- postoperative pain score
Study Overview
Brief Summary
Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. All the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA physical status I-II
- •undergoing elective total knee arthroplasty under spinal anesthesia
Exclusion Criteria
- •history of stomack ulceration
- •increased ICP
- •bronchial asthma
- •allergy on aspirin, NSAIDs, Nefopam
- •drug user of antiplatelet or anticoagulant
Arms & Interventions
opioid group
IV-PCA consisted of fentanyl
Intervention: Fentanyl (Drug)
non-opioid group
IV-PCA consisted of ketorolac and nefopam
Intervention: ketorolac tromethamine with nefopam hydrochloride (Drug)
Outcomes
Primary Outcomes
postoperative pain score
Time Frame: 24 hours after the surgery
evaluated by visual analogue scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Se-Hee Min
Assistant professor
Chung-Ang University Gwangmyeong Hospital