CPL-01 in the Management of Postoperative Pain After Bunionectomy

NCT05831449 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: CPL-01-302
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain; Bunion

Outcome Measures

Primary Outcomes (1)

• Cumulative Pain Score

  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

Study Arms (3)

CPL-01

EXPERIMENTAL

Local infiltration of study drug

Drug: Local anesthetic injection of CPL-01; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy

Ropivacaine HCl

ACTIVE COMPARATOR

Local infiltration of study drug

Drug: Naropin, 0.5% Injectable Solution; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy

Placebo

PLACEBO COMPARATOR

Local infiltration of study drug

Drug: Placebo; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy

Interventions

Local anesthetic injection of CPL-01 DRUG

Local anesthetic injection (CPL-01)

Also known as: CPL-01, Long-acting ropivacaine

CPL-01

Placebo DRUG

Local anesthetic injection (negative control \[saline placebo\])

Also known as: Saline placebo

Placebo

Morphine rescue medication DRUG

Rescue opioid (IV morphine) allowed if requested

Also known as: Opioids (intravenous [IV] morphine)

CPL-01; Placebo; Ropivacaine HCl

Acetaminophen rescue medication DRUG

Rescue non-opioid (oral acetaminophen) allowed if requested

Also known as: Non-opioid oral acetaminophen

CPL-01; Placebo; Ropivacaine HCl

Oxycodone rescue medication DRUG

Rescue opioid (PO oxycodone) allowed if requested

Also known as: Opioids (oral [PO] oxycodone)

CPL-01; Placebo; Ropivacaine HCl

Bunionectomy PROCEDURE

Operative bunion repair

Also known as: Bunion repair

CPL-01; Placebo; Ropivacaine HCl

Naropin, 0.5% Injectable Solution DRUG

Local anesthetic injection (positive control \[Naropin\])

Also known as: ropivacaine HCl

Ropivacaine HCl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cali Pharmaceuticals LLC: lead

Study Sites (1)

Todd Bertoch

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Conditions

Bunion; Pain, Postoperative

Interventions

Ropivacaine; Analgesics, Opioid; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• Erol Onel

  Cali Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 26, 2023
• Study Start: May 22, 2023
• Primary Completion: September 25, 2025
• Study Completion: October 6, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)