Pain Relief After PrimaryTKA

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Primary Purpose

Status

Enrolling by invitation

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

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

Bupivacaine HCl 0.5% Injectable Solution

primary total knee replacement

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

primary total knee replacement + Zynrelef

primary total knee replacement + adductor canal block (ACB)

Arm Description

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

Patients undergoing primary total knee replacement with routine adductor canal block

Outcomes

Primary Outcome Measures

Postoperative pain

This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant

Opioid consumption

Participants will be asked to keep a diary of how much pain medication they took after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT05751421

First Posted

February 21, 2023

Last Updated

March 1, 2023

Sponsor

Rothman Institute Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT05751421

Brief Title

Pain Relief After PrimaryTKA

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 28, 2023 (Anticipated)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

primary total knee replacement + Zynrelef

Arm Type

Experimental

Arm Description

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

Arm Title

primary total knee replacement + adductor canal block (ACB)

Arm Type

Active Comparator

Arm Description

Patients undergoing primary total knee replacement with routine adductor canal block

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

zynrelef will be administered during surgery

Intervention Type

Drug

Intervention Name(s)

Bupivacaine HCl 0.5% Injectable Solution

Intervention Description

adductor canal block will be performed using bupivacaine before surgery

Intervention Type

Procedure

Intervention Name(s)

primary total knee replacement

Intervention Description

primary total knee replacement

Primary Outcome Measure Information:

Title

Postoperative pain

Description

This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant

Time Frame

14 days

Title

Opioid consumption

Description

Participants will be asked to keep a diary of how much pain medication they took after surgery

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Rothman Orthopaedic Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Pain, Postoperative

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial