Pain Relief After PrimaryTKA

NCT ID: NCT05751421

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-02-28

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

primary total knee replacement + Zynrelef

Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)

Group Type: EXPERIMENTAL

Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution

Intervention Type: DRUG

zynrelef will be administered during surgery

primary total knee replacement

Intervention Type: PROCEDURE

primary total knee replacement

primary total knee replacement + adductor canal block (ACB)

Patients undergoing primary total knee replacement with routine adductor canal block

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl 0.5% Injectable Solution

Intervention Type: DRUG

adductor canal block will be performed using bupivacaine before surgery

primary total knee replacement

Intervention Type: PROCEDURE

primary total knee replacement

Interventions

Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution

zynrelef will be administered during surgery

Intervention Type: DRUG

Bupivacaine HCl 0.5% Injectable Solution

adductor canal block will be performed using bupivacaine before surgery

Intervention Type: DRUG

primary total knee replacement

primary total knee replacement

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

iRIS1128_JLON

Identifier Type: -

Identifier Source: org_study_id