Pain Relief After PrimaryTKA

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05751421

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	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	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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	Drug: Bupivacaine HCl 0.5% Injectable Solution adductor canal block will be performed using bupivacaine before surgery Procedure: primary total knee replacement primary total knee replacement

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

Drug: Bupivacaine HCl 0.5% Injectable Solution

adductor canal block will be performed using bupivacaine before surgery

Procedure: primary total knee replacement

primary total knee replacement

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT05751421

Other Study ID Numbers:

iRIS1128_JLON

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Meloxicam

Bupivacaine

Pharmaceutical Solutions

Study Results

No Results Posted as of Mar 2, 2023