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

C

Chung-Ang University Gwangmyeong Hospital

Status

Completed

Conditions

Postoperative Pain, Acute

Treatments

Drug: ketorolac tromethamine with nefopam hydrochloride
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT05861791
2210033049

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

60 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

opioid group
Experimental group
Description:
IV-PCA consisted of fentanyl
Treatment:
Drug: Fentanyl
non-opioid group
Active Comparator group
Description:
IV-PCA consisted of ketorolac and nefopam
Treatment:
Drug: ketorolac tromethamine with nefopam hydrochloride

Trial contacts and locations

1

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Central trial contact

Se-Hee Min

Data sourced from clinicaltrials.gov

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