CPL-01 in the Management of Postoperative Pain After Bunionectomy

Phase 3

Recruiting

• Conditions: Bunion
• Interventions: Drug: Local anesthetic injection of CPL-01; Drug: Placebo; Drug: Naropin, 0.5% Injectable Solution

• Registration Number: NCT05831449
• Lead Sponsor: Cali Pharmaceuticals LLC

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.

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 Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-26
• Study Start: 2023-05-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 574

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPL-01	Local anesthetic injection of CPL-01	Local infiltration of study drug
Placebo	Placebo	Local infiltration of study drug
Ropivacaine HCl	Naropin, 0.5% Injectable Solution	Local infiltration of study drug

Primary Outcome Measures

Name	Time	Method
Cumulative Pain Score	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.

Trial Locations

Locations (1)

Todd Bertoch; 🇺🇸 Salt Lake City, Utah, United States