Pain Relief After PrimaryTKA

March 1, 2023 updated by: Rothman Institute Orthopaedics

Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: primary total knee replacement + Zynrelef
Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution
zynrelef will be administered during surgery
Procedure: primary total knee replacement
primary total knee replacement
Active Comparator: primary total knee replacement + adductor canal block (ACB)
Patients undergoing primary total knee replacement with routine adductor canal block
Procedure: primary total knee replacement
primary total knee replacement
Drug: Bupivacaine HCl 0.5% Injectable Solution
adductor canal block will be performed using bupivacaine before surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2023

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRIS1128_JLON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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