Liposome Bupivacaine for ANKLE Blocks (NCT03106545) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Change in current pain over the first postoperative week
Timeframe: From baseline (before nerve block) through first postoperative week
2
Change in worst pain over the first postoperative week
Timeframe: From discharge from PACU through first postoperative week