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

July 11, 2024 updated by: Se-Hee Min, Chung-Ang University Gwangmyeong Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gwangmyeon-si
      • Gyeonggi-do, Gwangmyeon-si, Korea, Republic of, 14353
        • ChungAng University Gwangmyeong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: opioid group
IV-PCA consisted of fentanyl
Drug: Fentanyl
opioid group receives only fentanyl citrate 1200mcg for continuous infusion drug
Other Names:
  • opioid group
Active Comparator: non-opioid group
IV-PCA consisted of ketorolac and nefopam
Drug: ketorolac tromethamine with nefopam hydrochloride
non-opioid group receives ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score
Time Frame: 24 hours after the surgery
evaluated by visual analogue scale
24 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University Gwangmyeong Hospital

Investigators

  • Principal Investigator: Se-Hee Min, ChungAng University Gwangmyeon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2210033049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain, Acute

Clinical Trials on Fentanyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe