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Herniorrhaphy for Postoperative Pain

NCT05813847 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2026-04-30

No results posted yet for this study

Summary

Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.

Conditions

  • Hernia, Inguinal
  • Post Operative Pain

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

Sponsors & Collaborators

  • Cali Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Erol Onel · Cali Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2025-09-15
Completion
2025-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813847 on ClinicalTrials.gov