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Enrolling By Invitation
NCT05751421
Pain Relief After PrimaryTKA
Conditions: Pain, Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 60
Sponsor: Rothman Institute Orthopaedics
Location: United States
Summary
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery.
Traditionally, opioid medications have been used to control postoperative pain.
However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly.
In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
Eligibility Criteria
Inclusion Criteria:Patients 18 years or olderPatients undergoing primary unilateral TKAPatients receiving spinal anesthesia during primary TKAPatients with adequate cognitive function to participate and complete questionnaires for the studyExclusion Criteria:Patients undergoing bilateral simultaneous TKAPatients undergoing conversion TKAPatients undergoing unicompartmental knee arthroplastyPatients undergoing patellofemoral arthroplastyPatients with an allergy to NSAIDs or bupivacainePatients who have a contraindication to the use of NSAIDsPatients who are using chronic anticoagulation, precluding them from using NSAIDsPatients with a history or diagnosis of chronic pain syndrome or complex regional pain syndromePatients who are determined to be in severe pain from other concomitant conditionsPatients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.
Source: ClinicalTrials.gov (NCT05751421). StuddyBuddy aggregates publicly available trial information.