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NCT05751421

Pain Relief After PrimaryTKA

Status unknown Phase 3 Last updated 2 March 2023
What this trial tests

Phase 3 trial testing Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution in Pain, Postoperative in 60 participants. Status unknown.

Timeline
28 February 2023
Primary endpoint
28 February 2024
28 February 2024

Quick facts

Lead sponsorRothman Institute Orthopaedics
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date28 February 2023
Primary completion28 February 2024
Estimated completion28 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rothman Institute Orthopaedics

Who can join

18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

Other Rothman Institute Orthopaedics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05751421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing