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Pain Relief After PrimaryTKA

NCT05751421 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-02

No results posted yet for this study

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

Interventions

DRUG

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

zynrelef will be administered during surgery

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-02-28
Completion
2024-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751421 on ClinicalTrials.gov