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

NCT ID: NCT05861791

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-07-12

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.

Conditions

Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

opioid group

IV-PCA consisted of fentanyl

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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

non-opioid group

IV-PCA consisted of ketorolac and nefopam

Group Type: ACTIVE_COMPARATOR

ketorolac tromethamine with nefopam hydrochloride

Intervention Type: DRUG

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

Interventions

Fentanyl

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

Intervention Type: DRUG

ketorolac tromethamine with nefopam hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

opioid group

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung-Ang University Gwangmyeong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Se-Hee Min

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Se-Hee Min

Role: PRINCIPAL_INVESTIGATOR

ChungAng University Gwangmyeon Hospital

Locations

ChungAng University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeon-si, South Korea

Countries

South Korea

Other Identifiers

2210033049

Identifier Type: -

Identifier Source: org_study_id