Back to resultsComparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Primary Purpose
Postoperative Pain, Acute
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fentanyl
ketorolac tromethamine with nefopam hydrochloride
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain, Acute
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
Sites / Locations
- ChungAng University Gwangmyeong HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
opioid group
non-opioid group
Arm Description
IV-PCA consisted of fentanyl
IV-PCA consisted of ketorolac and nefopam
Outcomes
Primary Outcome Measures
pain score
evaluated by visual analogue scale (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT05861791
First Posted
February 8, 2023
Last Updated
May 18, 2023
Sponsor
Chung-Ang University Gwangmyeong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05861791
Brief Title
Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Gwangmyeong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
opioid group
Arm Type
Experimental
Arm Description
IV-PCA consisted of fentanyl
Arm Title
non-opioid group
Arm Type
Active Comparator
Arm Description
IV-PCA consisted of ketorolac and nefopam
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
opioid group
Intervention Description
opioid group receives only fentanyl citrate 1200mcg for continuous infusion drug
Intervention Type
Drug
Intervention Name(s)
ketorolac tromethamine with nefopam hydrochloride
Intervention Description
non-opioid group receives ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug
Primary Outcome Measure Information:
Title
pain score
Description
evaluated by visual analogue scale (VAS)
Time Frame
24 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se-Hee Min
Phone
821054004892
Email
seiheemin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se-Hee Min
Organizational Affiliation
ChungAng University Gwangmyeon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChungAng University Gwangmyeong Hospital
City
Gyeonggi-do
State/Province
Gwangmyeon-si
ZIP/Postal Code
14353
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-Hee Min
Phone
821054004892
Email
seiheemin@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
We'll reach out to this number within 24 hrs