Pain Relief After PrimaryTKA

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05751421
• Other study ID #: iRIS1128_JLON
• Status: Enrolling by invitation
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Pain, Postoperative

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