Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery

NCT06946368 | Recruiting

• 1 other identifier: 25-033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Exparel; Primary Unilateral Total Knee Arthroplasty; IPSA block

Outcome Measures

Primary Outcomes (6)

• Questionnaires to assess the Pain levels of subjects enrolled in the study

  Patients answer survey questionnaires about knee pain and general health. Pain levels will be taken regularly at 8, 24, 48 and 72 hours after surgery at the healthcare facility. Follow up questionnaire on pain levels will be done at 14 days and 90 days post-surgery. Patients share how satisfied they are with pain management at 72 hours, 14 days and 90 days after surgery. Subject's Reported Pain (Numeric Rating Scale) Pain intensity scores Subject will evaluate their pain in the operative knee using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain.

  120 days

• Evaluate safety and any side effects

  Record any (i.e., adverse events \[AEs\]) related to the EXPAREL IPSA block for the enrolled subjects.

  120 days

• Medication usage

  Information about concomitant medication usage including opioids and analgesics

  120 days

• Subject Satisfaction Assessments

  Subject Satisfaction Assessments (Likert Scale) Subject Satisfaction with Pain Management Overall satisfaction with your pain management. (Select one number only) 1. Extremely dissatisfied 2. Dissatisfied 3. Neither satisfied nor dissatisfied 4. Satisfied 5. Extremely satisfied

  120 days

• Knee and general health survey

  Questionnaires on knee health and general health. KOOS JR : Knee function will be assessed by the KOOS-JR questionnaire Forgotten Joint Score - 12: Joint Awareness questionnaires The Veterans RAND 12 Item Health Survey (VR-12): Health related quality of life will be assessed by the VR-12

  120 days

• Body Mass Index

  weight and height measurements will be taken and calculated to report BMI in kg/m\^2).

  120 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

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

Group 2-Control (Standard of Care)

ACTIVE COMPARATOR

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

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

Group 3

EXPERIMENTAL

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

Procedure: Local Infiltration Analgesia (LIA) of EXPAREL

Interventions

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

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 1

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

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 2-Control (Standard of Care)

Local Infiltration Analgesia (LIA) of EXPAREL PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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)
• Planned concurrent surgical procedure (e.g., bilateral TKA)
• Undergoing unicompartmental TKA or revision TKA
• 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
• Inadequate sensory function below the knee as assessed by the Investigator
• History of contralateral TKA within 1 year
• Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
• 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
• Previous participation in an EXPAREL study
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
• Currently pregnant, nursing, or planning to become pregnant during the study
• 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.
• 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
• Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113, United States

RECRUITING

Related Publications (2)

• Zhao Y, Huang Z, Ma W. Comparison of adductor canal block with local infiltration analgesia in primary total knee arthroplasty: A meta-analysis of randomized controlled trials. Int J Surg. 2019 Sep;69:89-97. doi: 10.1016/j.ijsu.2019.07.024. Epub 2019 Jul 30.

  PMID: 31374265 BACKGROUND

• Piuzzi NS, Spitzer AI, Mussell J, Pasqualini I, Dysart S, Gonzales J, Mont MA, Lonner JH, Mihalko W. Validation of a Novel Landmark-guided Intra-articular Postero-medial Surgeon-administered Injection Technique. Arthroplast Today. 2025 Jan 25;31:101619. doi: 10.1016/j.artd.2025.101619. eCollection 2025 Feb.

  PMID: 39927121 BACKGROUND

Study Officials

• Matthew Deren, MD

  Associate Staff Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanalkumar Krishnan, PhD

CONTACT

216-445-7194; krishns11@ccf.org

Jaime Shuster, PhD

CONTACT

216- 906-0508; shustej3@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized pilot study. The study will enroll 60 total subjects 1:1:1 to receive treatment on the day of surgery. The randomization code will be computer-generated.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 27, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)