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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Adults over age 19

• Patients undergoing total knee arthroplasty for osteoarthritis of the knee joint

• Patients with a pain VAS scale of 4 or more out of 10 after TKA with a pain in the knee joint during daily activities on flat ground

• Patients who are willing or able to follow doctor's instructions, including joint exercises

• Patients not participating in other clinical trials

• Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion Criteria:

• Patients with secondary knee osteoarthritis

• Patients with hypersensitivity reactions and serious side effects to duloxetine or opioid

• Patients with inflammatory arthritis or crystalline arthritis

• Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.

• Patients who underwent meniscus surgery on the knee joint in the painful area

• If there is construction or deformation of the knee joint in the pain area

• Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease

• Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of> 150 mmHg or Diastolic Blood Pressure> 95 mmHg)

• Patients with abnormal liver function (ALT)> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine> 2.0 times ULN)