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Herniorrhaphy for Postoperative Pain

Primary Purpose

Hernia, Inguinal

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
local anaesthetic injection
Sponsored by
Cali Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to sign Informed Consent Scheduled to have inguinal hernia repair Be a reasonably healthy adult 18 - 75 years of age Body mass index ≤ 39 kg/m2 If biologically female, not pregnant or planning to become pregnant If biologically male, using acceptable birth control Be willing and able to complete study procedures Exclusion Criteria: Previously inguinal herniorrhaphy Concurrent painful condition that may require analgesic treatment History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. Impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis. Impaired renal function (e.g., creatinine > 1.5 × ULN). Malignancy in the past year Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

Sites / Locations

  • Todd BertochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CPL-01

Ropivacaine HCl

Placebo

Arm Description

Local infiltration of CPL-01

Local infiltration of Naropin

Local infiltration of Saline Placebo

Outcomes

Primary Outcome Measures

Pain control
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
August 28, 2023
Sponsor
Cali Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05813847
Brief Title
Herniorrhaphy for Postoperative Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cali Pharmaceuticals LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPL-01
Arm Type
Experimental
Arm Description
Local infiltration of CPL-01
Arm Title
Ropivacaine HCl
Arm Type
Active Comparator
Arm Description
Local infiltration of Naropin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Local infiltration of Saline Placebo
Intervention Type
Drug
Intervention Name(s)
local anaesthetic injection
Intervention Description
Local infiltration of study drug
Primary Outcome Measure Information:
Title
Pain control
Description
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to sign Informed Consent Scheduled to have inguinal hernia repair Be a reasonably healthy adult 18 - 75 years of age Body mass index ≤ 39 kg/m2 If biologically female, not pregnant or planning to become pregnant If biologically male, using acceptable birth control Be willing and able to complete study procedures Exclusion Criteria: Previously inguinal herniorrhaphy Concurrent painful condition that may require analgesic treatment History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. Impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis. Impaired renal function (e.g., creatinine > 1.5 × ULN). Malignancy in the past year Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erol Onel
Phone
2038376500
Email
e.onel@calibiosciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erol Onel
Organizational Affiliation
Cali Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Todd Bertoch
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Bertoch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Herniorrhaphy for Postoperative Pain

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