Recruiting

IPSA Block & LIA

Sponsor:

The Cleveland Clinic

Code:

NCT06946368

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Intra-articular Posteromedial Surgeon Administered (IPSA) Block of EXPAREL

Adductor Canal Block (ACB) and Local Local Infiltration Analgesia of EXPAREL

Local Infiltration Analgesia (LIA) of EXPAREL

Study Details

Brief summary:

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.

Conditions

Total Knee Arthroplasty

Study ID

NCT06946368

Start date

Aug 18, 2025

Status verified date

Sep, 2025

Completion date

Dec 11, 2026

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

1\. Subjects ages 18 or older at screening 2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia 3. Primary indication for TKA is degenerative osteoarthritis of the knee 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 6) 5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 6. Body Mass Index (BMI) ≥18 and <40 kg/m2

\-

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA).

active comparator: Group 2-Control (Standard of Care)

Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA).

experimental: Group 3

Patients in this group will receive Local Infiltration Analgesia (LIA).

Interventions

Intra-articular Posteromedial Surgeon Administered (IPSA) Block of EXPAREL

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.

Adductor Canal Block (ACB) and Local Local Infiltration Analgesia of EXPAREL

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.

Local Infiltration Analgesia (LIA) of EXPAREL

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.

Primary outcome measure

  • Questionnaires to assess the Pain levels of subjects enrolled in the study [ Time Frame: 120 days ]
  • Evaluate safety and any side effects [ Time Frame: 120 days ]
  • Medication usage [ Time Frame: 120 days ]
  • Subject Satisfaction Assessments [ Time Frame: 120 days ]
  • Knee and general health survey [ Time Frame: 120 days ]
  • Body Mass Index [ Time Frame: 120 days ]

Central Contacts and Locations

Central contacts

Sanalkumar Krishnan, PhD

216-445-7194krishns11@ccf.org

Locations

Cleveland Clinic Lutheran Hospital

Recruiting

Cleveland, Ohio, United States, 44113

Contacts

Principal Investigator:

Matthew Deren, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • Exparel
  • Primary Unilateral Total Knee Arthroplasty
  • IPSA block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-09-10.