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COMPLETED
NCT05813847
PHASE3

Herniorrhaphy for Postoperative Pain

Sponsor: Cali Pharmaceuticals LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

local anaesthetic injection of CPL-01

Local infiltration of study drug

DRUG

Morphine (rescue medication)

Opioid rescue allowed by IV if requested

DRUG

Acetaminophen (rescue medication)

Acetaminophen rescue allowed if requested

DRUG

Oxycodone (rescue medication)

Opioid rescue allowed by mouth if requested

DRUG

local anaesthetic injection of placebo

Local infiltration of study drug

DRUG

local anaesthetic injection of ropivacaine HCl

Local infiltration of study drug

PROCEDURE

Open inguinal hernia repair

Surgical hernia repair

Locations (1)

Todd Bertoch

Salt Lake City, Utah, United States