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Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: RCT

NCT04719585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-01-22

No results posted yet for this study

Summary

Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. In this study, we want to investigate the difference of the result among patients who undego total knee arthroplasty (TKA), of the result of pain control after TKA from SNRI administration of duloxetine and opioid in two groups. We designed a randomized controlled study (RCT) for the effect of post-TKA pain control to determine whether SNRI is effective in controlling post-TKA pain compared to Opioid, and whether there is a difference in side effects.

Conditions

  • Total Knee Arthroplasty
  • Osteoarthritis, Knee

Interventions

DRUG

Duloxetine vs. Opioid

Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine or opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719585 on ClinicalTrials.gov