Liposome Bupivacaine for WRIST Blocks (NCT03106519) | Clinical Trial Compass
CompletedPhase 2
Liposome Bupivacaine for WRIST Blocks
Belgium32 participantsStarted 2017-01-02
Plain-language summary
Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with less pain.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 85 years of age at screening
* Scheduled to undergo Dupuytren's contracture release
* American Society of Anesthesiologists (ASA) physical status I, II or III
* Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch
* Female subjects must be surgically sterile or have a monogamous partner who is surgically sterile; 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 understand the English or Dutch language, purpose and risks of the study
* Able to provide informed consent and authorization to use protected health information, 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 moth after study drug administration
* History of hypersensitivity to local anesthetics
* Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine
* Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff
* Chronic scheduled use of any of the following medications within the times s…
What they're measuring
1
Change in current pain over the first postoperative week
Timeframe: From baseline (before nerve block) through first postoperative week