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NCT03106545

Liposome Bupivacaine for ANKLE Blocks

Completed Phase 2 Last updated 11 September 2020
What this trial tests

Phase 2 trial testing Liposome bupivacaine in Hallux Valgus (Bunions) in 40 participants. Completed in 31 October 2017.

Timeline
2 January 2017
Primary endpoint
26 June 2017
31 October 2017

Quick facts

Lead sponsorCatherine Vandepitte, M.D.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment40
Start date2 January 2017
Primary completion26 June 2017
Estimated completion31 October 2017
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Catherine Vandepitte, M.D. — full company profile →

Who can join

Adults 18 to 65, any sex, with Hallux Valgus (Bunions). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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