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Herniorrhaphy for Postoperative Pain
Sponsor: Cali Pharmaceuticals LLC
Summary
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
518
Start Date
2023-04-18
Completion Date
2025-10-06
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
local anaesthetic injection of CPL-01
Local infiltration of study drug
Morphine (rescue medication)
Opioid rescue allowed by IV if requested
Acetaminophen (rescue medication)
Acetaminophen rescue allowed if requested
Oxycodone (rescue medication)
Opioid rescue allowed by mouth if requested
local anaesthetic injection of placebo
Local infiltration of study drug
local anaesthetic injection of ropivacaine HCl
Local infiltration of study drug
Open inguinal hernia repair
Surgical hernia repair
Locations (1)
Todd Bertoch
Salt Lake City, Utah, United States