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

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChungAng University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeon-si, 14353, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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

Other names: opioid group

ketorolac tromethamine with nefopam hydrochloride

Drug

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

Primary outcomes

postoperative pain score

Time frame: 24 hours after the surgery

evaluated by visual analogue scale

Sponsors and collaborators

Lead sponsor

Chung-Ang University Gwangmyeong Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 17, 2023
Registry last updated: Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed