RECRUITING

Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery

Conditions

Total Knee Arthroplasty Exparel Primary Unilateral Total Knee Arthroplasty IPSA block

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Intra-articular Posteromedial Surgeon Administered (IPSA) Block in this study describes a new type of medical procedure where a surgeon provides anesthetic medication directly into a specific area inside a knee joint to numb the pain during knee surgery. Intra-articular refers to inside of knee joint, posteromedial refers to the back and inner side of a knee joint, and surgeon administered means a surgeon is performing the procedure. Patients You will be randomly assigned to one of these three treatment groups: Group 1: Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA). IPSA block is a pain numbing medication given by surgeon and injected inside the back and inner side of the knee joint. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 2 (Control): Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA). ACB is a pain numbing injection given by anesthesiologist near the adductor canal, a passage in the mid-thigh that contains nerves connecting the knee region. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 3: Patients in this group will receive Local Infiltration Analgesia (LIA). Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. The study will evaluate; * How effective the pain relief is after surgery. * How much extra pain medication you need. * Your satisfaction with pain management and recovery * Any side effects.

Official Title

A Single-Center, Randomized, Pilot Study to Assess the Clinical Effectiveness of EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

Quick Facts

Study Start:2025-08-18

Study Completion:2026-12-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06946368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study: 1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs) 2. Planned concurrent surgical procedure (e.g., bilateral TKA) 3. Undergoing unicompartmental TKA or revision TKA 4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments 5. Inadequate sensory function below the knee as assessed by the Investigator 6. History of contralateral TKA within 1 year 7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted 8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years 9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study 10. Previous participation in an EXPAREL study 11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance 12. Currently pregnant, nursing, or planning to become pregnant during the study 13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study. 14. Any use of marijuana \[including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)\] within 30 days prior to randomization, or planned use during the course of the study 15. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study:
1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
2. Planned concurrent surgical procedure (e.g., bilateral TKA)
3. Undergoing unicompartmental TKA or revision TKA
4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments
5. Inadequate sensory function below the knee as assessed by the Investigator
6. History of contralateral TKA within 1 year
7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted
8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
10. Previous participation in an EXPAREL study
11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
12. Currently pregnant, nursing, or planning to become pregnant during the study
13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
14. Any use of marijuana \[including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)\] within 30 days prior to randomization, or planned use during the course of the study
15. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery

Contacts and Locations

Study Contact

Sanalkumar Krishnan, PhD

CONTACT

216-445-7194

krishns11@ccf.org

Jaime Shuster, PhD

CONTACT

216- 906-0508

shustej3@ccf.org

Principal Investigator

Matthew Deren, MD

PRINCIPAL_INVESTIGATOR

Associate Staff Orthopaedic Surgery

Study Locations (Sites)

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Matthew Deren, MD, PRINCIPAL_INVESTIGATOR, Associate Staff Orthopaedic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18

Study Completion Date2026-12-11

Study Record Updates

Study Start Date2025-08-18

Study Completion Date2026-12-11

Terms related to this study

Keywords Provided by Researchers

Exparel
Primary Unilateral Total Knee Arthroplasty
IPSA block

Additional Relevant MeSH Terms

Total Knee Arthroplasty