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.
None
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
Parallel
Intra-articular Posteromedial Surgeon Administered (IPSA) Block of EXPAREL
Procedure/SurgeryPatients 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/SurgeryACB 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/SurgeryLocal 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.
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.
Evaluate safety and any side effects
Record any (i.e., adverse events \[AEs\]) related to the EXPAREL IPSA block for the enrolled subjects.
Medication usage
Information about concomitant medication usage including opioids and analgesics
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
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
Pacira Pharmaceuticals, Inc
Collaborator
