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Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05861791
Enrollment
98
Registered
2023-05-17
Start date
2023-02-07
Completion date
2024-07-12
Last updated
2024-07-15

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

Conditions

Postoperative Pain, Acute

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.

Interventions

DRUGFentanyl

opioid group receives only fentanyl citrate 1200mcg for continuous infusion drug

DRUGketorolac tromethamine with nefopam hydrochloride

non-opioid group receives ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug

Sponsors

Chung-Ang University Gwangmyeong Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 79 Years
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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain score24 hours after the surgeryevaluated by visual analogue scale

Countries

South Korea

Outcome results

None listed

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