Actively Recruiting
Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery
Led by The Cleveland Clinic · Updated on 2025-09-10
60
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
P
Pacira Pharmaceuticals, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Scheduled for primary unilateral total knee arthroplasty under spinal anesthesia
- Primary reason for surgery is degenerative osteoarthritis of the knee
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to give informed consent, follow the study schedule, and complete all assessments
- Body Mass Index (BMI) of 18 to less than 40 kg/m2
You will not qualify if you...
- Allergy or intolerance to study medications with no alternative available (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Planned concurrent surgical procedures like bilateral knee replacement
- Undergoing unicompartmental or revision total knee arthroplasty
- Other painful conditions needing pain treatment that could affect study results
- Reduced sensation below the knee as assessed by the investigator
- History of knee replacement on the other leg within 1 year
- Previous open knee surgery on the study knee (prior arthroscopy allowed)
- History or current addiction or abuse of drugs, prescription medicines, or alcohol within 2 years
- Use of investigational drugs within 30 days or planned investigational treatments during study
- Previous participation in an EXPAREL study
- Uncontrolled psychiatric conditions interfering with study participation
- Pregnant, nursing, or planning pregnancy during the study
- Significant medical conditions making study participation unsafe (e.g., diabetic neuropathy, bleeding disorders, severe vascular disease, kidney or liver problems)
- Use of marijuana (THC or CBD) within 30 days prior to randomization or planned use during study
- Chronic opioid use averaging 30 or more oral morphine equivalents per day within 30 days before surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio, United States, 44113
Actively Recruiting
Research Team
S
Sanalkumar Krishnan, PhD
CONTACT
J
Jaime Shuster, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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