Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-03 @ 9:41 AM
Study NCT ID:
NCT06946368
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
A Single-Center, Randomized, Pilot Study to Assess the Clinical Effectiveness of EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
The study is a single-center, randomized, pilot study and will recruit up to 60 adult subjects undergoing unilateral total knee arthroplasty. Subjects will be randomized (1:1:1) to receive the treatments. The study participants will be followed for up to 90 days.
Information on analgesic use, pain, satisfaction with pain management will be obtained from patients. Participation begins when you sign the consent form. The treatment will begin on the day of the surgery. Follow up calls will be done 14 days and 90 days after surgery. Your involvement will last about 123 days.
Background and Rationale for the Study:
This study is being conducted to evaluate the clinical effectiveness of the Intra-articular Posteromedial Surgeon Administered (IPSA) block in subjects undergoing total knee arthroplasty (TKA). This study aims to demonstrate that a surgeon administered IPSA block can provide equivalent pain control to an anesthesiologist administered adductor canal block (ACB).
Method of Assigning Subjects to Treatment Randomization Scheme
Randomization Procedures Once a subject is identified as being qualified for the study in accordance with the eligibility criteria, the Investigator or designee will obtain a randomization assignment on the day of surgery. The subject will be considered randomized to the study once the study treatment is assigned.
Replacement of Subjects Subjects who withdraw from the study before the study treatment procedure may be replaced. Once a subject number is assigned, subject numbers will not be reused; subjects enrolled to replace those who withdraw will be assigned a unique subject number and randomized to treatment according to the procedures outlined above.
Subjects who are randomized but are withdrawn from the study before receiving the study drug may be replaced. Additionally, subjects may be replaced if insufficient and/or incomplete data are noted on safety or clinical outcomes.
Information on analgesic use, pain, satisfaction with pain management will be obtained from patients. Participation begins when you sign the consent form. The treatment will begin on the day of the surgery. Follow up calls will be done 14 days and 90 days after surgery. Your involvement will last about 123 days.
Background and Rationale for the Study:
This study is being conducted to evaluate the clinical effectiveness of the Intra-articular Posteromedial Surgeon Administered (IPSA) block in subjects undergoing total knee arthroplasty (TKA). This study aims to demonstrate that a surgeon administered IPSA block can provide equivalent pain control to an anesthesiologist administered adductor canal block (ACB).
Method of Assigning Subjects to Treatment Randomization Scheme
Randomization Procedures Once a subject is identified as being qualified for the study in accordance with the eligibility criteria, the Investigator or designee will obtain a randomization assignment on the day of surgery. The subject will be considered randomized to the study once the study treatment is assigned.
Replacement of Subjects Subjects who withdraw from the study before the study treatment procedure may be replaced. Once a subject number is assigned, subject numbers will not be reused; subjects enrolled to replace those who withdraw will be assigned a unique subject number and randomized to treatment according to the procedures outlined above.
Subjects who are randomized but are withdrawn from the study before receiving the study drug may be replaced. Additionally, subjects may be replaced if insufficient and/or incomplete data are noted on safety or clinical outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: