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

NCT05861791 | Completed

• 1 other identifier: 2210033049
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  evaluated by visual analogue scale

  24 hours after the surgery

Study Arms (2)

opioid group

EXPERIMENTAL

IV-PCA consisted of fentanyl

Drug: Fentanyl

non-opioid group

ACTIVE COMPARATOR

IV-PCA consisted of ketorolac and nefopam

Drug: ketorolac tromethamine with nefopam hydrochloride

Interventions

Fentanyl DRUG

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

Also known as: opioid group

opioid group

ketorolac tromethamine with nefopam hydrochloride DRUG

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

non-opioid group

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II
• undergoing elective total knee arthroplasty under spinal anesthesia

You may not qualify if:

• history of stomack ulceration
• increased ICP
• bronchial asthma
• allergy on aspirin, NSAIDs, Nefopam
• drug user of antiplatelet or anticoagulant

Sponsors & Collaborators

• Chung-Ang University Gwangmyeong Hospital: lead

Study Sites (1)

ChungAng University Gwangmyeong Hospital

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

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Ketorolac Tromethamine; Nefopam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Oxazocines; Azocines

Study Officials

• Se-Hee Min

  ChungAng University Gwangmyeon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 17, 2023
• Study Start: February 7, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

KR (1)