CPL-01 in the Management of Postoperative Pain After Bunionectomy

April 23, 2026 updated by: Cali Pharmaceuticals LLC

A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards.

The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.

Study Type

Interventional

Enrollment (Actual)

616

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • Todd Bertoch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to sign ICF
  • Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
  • BMI ≤ 39 kg/m2
  • If biologically female, not pregnant or planning to become pregnant over the study
  • If biologically male, either sterile or using acceptable form of birth control
  • Be willing and able to complete study procedures

Exclusion Criteria:

  • Has previously undergone unilateral simple bunionectomy.
  • Has a planned concurrent surgical procedure
  • Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
  • Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
  • Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
  • Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
  • Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
  • Has a history of malignancy in the past year
  • Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPL-01
Local infiltration of study drug
Drug: Local anesthetic injection of CPL-01
Local anesthetic injection (CPL-01)
Other Names:
  • CPL-01
  • Long-acting ropivacaine
Drug: Morphine rescue medication
Rescue opioid (IV morphine) allowed if requested
Other Names:
  • Opioids (intravenous [IV] morphine)
Drug: Acetaminophen rescue medication
Rescue non-opioid (oral acetaminophen) allowed if requested
Other Names:
  • Non-opioid oral acetaminophen
Drug: Oxycodone rescue medication
Rescue opioid (PO oxycodone) allowed if requested
Other Names:
  • Opioids (oral [PO] oxycodone)
Procedure: Bunionectomy
Operative bunion repair
Other Names:
  • Bunion repair
Active Comparator: Ropivacaine HCl
Local infiltration of study drug
Drug: Morphine rescue medication
Rescue opioid (IV morphine) allowed if requested
Other Names:
  • Opioids (intravenous [IV] morphine)
Drug: Acetaminophen rescue medication
Rescue non-opioid (oral acetaminophen) allowed if requested
Other Names:
  • Non-opioid oral acetaminophen
Drug: Oxycodone rescue medication
Rescue opioid (PO oxycodone) allowed if requested
Other Names:
  • Opioids (oral [PO] oxycodone)
Procedure: Bunionectomy
Operative bunion repair
Other Names:
  • Bunion repair
Drug: Naropin, 0.5% Injectable Solution
Local anesthetic injection (positive control [Naropin])
Other Names:
  • ropivacaine HCl
Placebo Comparator: Placebo
Local infiltration of study drug
Drug: Morphine rescue medication
Rescue opioid (IV morphine) allowed if requested
Other Names:
  • Opioids (intravenous [IV] morphine)
Drug: Acetaminophen rescue medication
Rescue non-opioid (oral acetaminophen) allowed if requested
Other Names:
  • Non-opioid oral acetaminophen
Drug: Oxycodone rescue medication
Rescue opioid (PO oxycodone) allowed if requested
Other Names:
  • Opioids (oral [PO] oxycodone)
Procedure: Bunionectomy
Operative bunion repair
Other Names:
  • Bunion repair
Drug: Placebo
Local anesthetic injection (negative control [saline placebo])
Other Names:
  • Saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Pain Score
Time Frame: 72 hours
Area Under the Curve of the Numeric Rating Scale Score for Pain with Activity. Activity is resting the operative foot with the ball on the floor. Pain Score spans from 0 to 10, where 0 is no pain and 10 is worst pain imaginable.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cali Pharmaceuticals LLC

Investigators

  • Study Director: Erol Onel, Cali Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPL-01-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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