CompletedPhase 2

Liposome Bupivacaine for ANKLE Blocks

Belgium40 participantsStarted 2017-01-02

Plain-language summary

Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, at least 18 years and max 65 years of age at screening * Scheduled to undergo primary Scarf osteotomy for elective hallux valgus * American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 * Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study * Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch * Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations * Able to adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: * Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration * Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair) * Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain tha…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in current pain over the first postoperative week

Timeframe: From baseline (before nerve block) through first postoperative week

Change in worst pain over the first postoperative week

Timeframe: From discharge from PACU through first postoperative week

Trial details

NCT IDNCT03106545

SponsorCatherine Vandepitte, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-26

View on ClinicalTrials.gov More Hallux Valgus (Bunions) trials