This phase III trial compares the effect of ropivacaine, epinephrine, clonidine, and ketorolac (R.E.C.K) to Exparel on pain after undergoing surgery to remove part of one kidney or a kidney tumor (partial nephrectomy) or an entire kidney, nearby adrenal gland and lymph nodes and other surrounding tissue (radical nephrectomy). Pain control for patients undergoing surgery can begin in the operating room using regional pain medications. Ropivacaine, a type of local anesthetic, is a drug used to control pain and to cause a temporary loss of feeling in one part of the body, during and after surgery. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the airways and tightening the blood vessels. Clonidine blocks the release of chemicals from nerve endings that make blood vessels constrict (get narrower). Clonidine is a type of antihypertensive agent and a type of alpha-adrenergic agonist. Ketorolac is in a class of medications called non-steroidal anti-inflammatory drugs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation. Bupivacaine is in a class of medications called local anesthetics. It works by blocking nerves from sending pain signals. Exparel is a form of bupivacaine that is contained inside very tiny, fat-like particles. It slows the release of bupivacaine and may increase the duration of pain relief. Both R.E.C.K and Exparel have a similar purpose and are approved for use in post operative pain care, but the cost of Exparel is significantly more. Giving R.E.C.K may be as effective as Exparel on controlling pain and reducing the use of narcotics after a partial or radical nephrectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT07092566.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer InstituteStatus: Active
Contact: Ornob Roy
Phone: 704-355-8686
PRIMARY OBJECTIVE:
I. To compare the magnitude of the analgesic effect between the liposomal bupivacaine (Exparel) and R.E.C.K randomized cohorts from post operative day (POD)0 through POD7 by analysis of numerical rating scale (NRS) pain scores in participants intending to undergo robotic nephrectomy.
SECONDARY OBJECTIVES:
I. To compare the following between the Exparel and R.E.C.K cohorts:
Ia. The trajectory of average daily pain from POD0 through POD7;
Ib. Total postsurgical opioid consumption (in morphine equivalent dose, MED) from POD0 (starting with the end of surgery) through POD7;
Ic. The trajectory of daily postsurgical opioid consumption (in MED) from POD0 through POD7;
Id. Total postsurgical pain medication consumption (in milligrams) from POD0 through POD7 for each ibuprofen, acetaminophen, and naproxen;
Ie. The trajectories of daily consumption (in milligrams) from POD0 through POD7 for each ibuprofen, acetaminophen, and naproxen;
If. Proportions of participants opioid free at the end of POD7;
Ig. Time to first opioid intake;
Ih. Length of inpatient stay.
SAFETY OBJECTIVES:
I. To compare the following between the Exparel and R.E.C.K cohorts:
Ia. Study drug related adverse events from study drug initiation to 30 days after administration of study drug;
Ib. Serious adverse events from study drug initiation to 30 days after administration of study drug;
Ic. Surgical complications reported within 14 days after administration of study drug;
Id. 30-day post-discharge readmission rate;
Ie. 30-day post-discharge mortality rate.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive ropivacaine, epinephrine, clonidine, and ketorolac intramuscularly (IM) during robotic partial or radical nephrectomy.
ARM B: Patients receive liposomal bupivacaine IM during robotic partial or radical nephrectomy.
After completion of study intervention, patients are followed for up to 30 days.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorOrnob Roy
