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

Sponsor
Chung-Ang University Gwangmyeong Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05861791
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fentanyl
  • Drug: ketorolac tromethamine with nefopam hydrochloride
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official 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
Actual Study Start Date :
Feb 7, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 7, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. pain score [24 hours after the surgery]

      evaluated by visual analogue scale (VAS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChungAng University Gwangmyeong Hospital Gyeonggi-do Gwangmyeon-si Korea, Republic of 14353

    Sponsors and Collaborators

    • Chung-Ang University Gwangmyeong Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Se-Hee Min, Assistant professor, Chung-Ang University Gwangmyeong Hospital
    ClinicalTrials.gov Identifier:
    NCT05861791
    Other Study ID Numbers:
    • 2210033049
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 22, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acute Pain
    Ketorolac
    Ketorolac Tromethamine
    Fentanyl
    Nefopam

    Study Results

    No Results Posted as of May 22, 2023