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Clinical Trials/NCT05861791
NCT05861791CompletedNot Applicable

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

Chung-Ang University Gwangmyeong Hospital1 site in 1 country98 target enrollmentStarted: February 7, 2023Last updated:
Conditions
Interventions
Drugs

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

Experimental

IV-PCA consisted of fentanyl

Intervention: Fentanyl (Drug)

non-opioid group

Active Comparator

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

Sponsor
Chung-Ang University Gwangmyeong Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Se-Hee Min

Assistant professor

Chung-Ang University Gwangmyeong Hospital

Study Sites (1)

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