CLINICAL TRIALS PROFILE FOR EPINEPHRINE IN 0.9% SODIUM CHLORIDE

505(b)(2) Clinical Trials for Epinephrine In 0.9% Sodium Chloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

All Clinical Trials for Epinephrine In 0.9% Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	University of Minnesota	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.

Clinical Trial Conditions for Epinephrine In 0.9% Sodium Chloride

Condition Name

Condition Name for Epinephrine In 0.9% Sodium Chloride
Intervention	Trials
Pain	45
Postoperative Pain	38
Pain, Postoperative	33
Anesthesia, Local	22

Condition MeSH

Condition MeSH for Epinephrine In 0.9% Sodium Chloride
Intervention	Trials
Pain, Postoperative	101
Pulpitis	36
Hemorrhage	29
Osteoarthritis	23

Clinical Trial Locations for Epinephrine In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Epinephrine In 0.9% Sodium Chloride
Location	Trials
United States	426
Canada	66
Egypt	56
Korea, Republic of	25
China	24

Trials by US State

Trials by US State for Epinephrine In 0.9% Sodium Chloride
Location	Trials
California	54
New York	32
North Carolina	30
Maryland	25
Pennsylvania	25

Clinical Trial Progress for Epinephrine In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Epinephrine In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	34
PHASE3	12
PHASE2	15

Clinical Trial Status

Clinical Trial Status for Epinephrine In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Completed	389
RECRUITING	132
Not yet recruiting	82

Clinical Trial Sponsors for Epinephrine In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Epinephrine In 0.9% Sodium Chloride
Sponsor	Trials
University of California, San Diego	14
Cairo University	14
Assiut University	12

Sponsor Type

Sponsor Type for Epinephrine In 0.9% Sodium Chloride
Sponsor	Trials
Other	1038
Industry	92
NIH	30