NCT05751421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 21, 2023

Last Update Submit

March 1, 2023

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

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

    14 days

  • Opioid consumption

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

    14 days

Study Arms (2)

primary total knee replacement + Zynrelef

EXPERIMENTAL

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 SolutionProcedure: primary total knee replacement

primary total knee replacement + adductor canal block (ACB)

ACTIVE COMPARATOR

Patients undergoing primary total knee replacement with routine adductor canal block

Drug: Bupivacaine HCl 0.5% Injectable SolutionProcedure: primary total knee replacement

Interventions

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

zynrelef will be administered during surgery

primary total knee replacement + Zynrelef
Bupivacaine HCl 0.5% Injectable SolutionDRUG

adductor canal block will be performed using bupivacaine before surgery

primary total knee replacement + adductor canal block (ACB)
primary total knee replacementPROCEDURE

primary total knee replacement

primary total knee replacement + Zynrelefprimary total knee replacement + adductor canal block (ACB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

bupivacaine-meloxicam drug combinationBupivacaineMeloxicam

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesThiazinesSulfur CompoundsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 2, 2023

Study Start

February 28, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

US(1)