Pain Relief After PrimaryTKA

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution; Drug: Bupivacaine HCl 0.5% Injectable Solution; Procedure: primary total knee replacement

• Registration Number: NCT05751421
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study Start: 2023-02-28
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients 18 years or older
• Patients undergoing primary unilateral TKA
• Patients receiving spinal anesthesia during primary TKA
• Patients with adequate cognitive function to participate and complete questionnaires for the study

Exclusion Criteria

• Patients undergoing bilateral simultaneous TKA
• Patients undergoing conversion TKA
• Patients undergoing unicompartmental knee arthroplasty
• Patients undergoing patellofemoral arthroplasty
• Patients with an allergy to NSAIDs or bupivacaine
• Patients who have a contraindication to the use of NSAIDs
• Patients who are using chronic anticoagulation, precluding them from using NSAIDs
• Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
• Patients who are determined to be in severe pain from other concomitant conditions
• Patients 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
primary total knee replacement + Zynrelef	Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution	Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
primary total knee replacement + Zynrelef	primary total knee replacement	Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
primary total knee replacement + adductor canal block (ACB)	Bupivacaine HCl 0.5% Injectable Solution	Patients undergoing primary total knee replacement with routine adductor canal block
primary total knee replacement + adductor canal block (ACB)	primary total knee replacement	Patients undergoing primary total knee replacement with routine adductor canal block

Primary Outcome Measures

Name	Time	Method
Postoperative pain	14 days	This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant
Opioid consumption	14 days	Participants will be asked to keep a diary of how much pain medication they took after surgery

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States