Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06946368
Status
Recruiting
Apply to this trial

Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Sep 2025
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Questionnaires to assess the Pain levels of subjects enrolled in the study [ Time Frame: 120 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Lutheran HospitalClevelandOhio44113
Robert Molloy, MD
[email protected]
216-445-5226
Matthew Deren, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Lutheran Hospital· Cleveland, OH

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