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New shot could cut opioid use after bunion surgery

NCT ID NCT05831449

Symptom relief Sponsor: Cali Pharmaceuticals LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental long-acting local anesthetic called CPL-01 in 616 people having bunion surgery. The goal was to see if it reduces pain and the need for opioid painkillers after the operation compared to a standard anesthetic or a placebo. Participants received the injection during surgery and were monitored for pain levels and any rescue medication use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CPL-01 (long-acting ropivacaine local anesthetic injection)
What this could lead to
If it works, CPL-01 could provide longer-lasting pain relief after foot surgery and reduce the need for opioid painkillers.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than existing anesthetics or placebo, and individual responses to pain medication vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

616 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bunion Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bunion Post operative pain

Contacts and locations

Locations

  • Todd Bertoch

    Salt Lake City, Utah, 84101, United States

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