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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05751421
Other study ID # iRIS1128_JLON
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date February 28, 2023
Est. completion date February 28, 2024

Study information

Verified date February 2023
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution
zynrelef will be administered during surgery
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

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant 14 days
Primary Opioid consumption Participants will be asked to keep a diary of how much pain medication they took after surgery 14 days
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