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NCT02679560

Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

Terminated Phase 2 Results posted Last updated 21 February 2021
What this trial tests

Phase 2 trial testing Liposomal Bupivacaine in Femoral Fractures in 3 participants. Terminated before completion.

Timeline
1 October 2017
Primary endpoint
1 November 2019
1 November 2019

Quick facts

Lead sponsorIan Elliott Brown
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment3
Start date1 October 2017
Primary completion1 November 2019
Estimated completion1 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ian Elliott Brown

Who can join

Adults 18 to 70, any sex, with Femoral Fractures. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposomal Bupivacaine
Serious: 0/1 (0%)
Deaths: 0/1
Ropivacaine HCL
Serious: 0/2 (0%)
Deaths: 0/2
Other adverse events (14 terms — click to expand)

ReactionSystemLiposomal BupivacaineRopivacaine HCL
Mild edemaBlood and lymphatic system disorders
mild muscle spasmsMusculoskeletal and connective tissue disorders
hallucinationPsychiatric disorders
pruritusSkin and subcutaneous tissue disorders
diaphoresisNervous system disorders
urinary retentionRenal and urinary disorders
feverImmune system disorders
elevated systolic blood pressureBlood and lymphatic system disorders
tachypneaRespiratory, thoracic and mediastinal disorders
tachycardiaCardiac disorders
nauseaGastrointestinal disorders
constipationGastrointestinal disorders
moderate orthostatic hypotensionNervous system disorders
anemiaBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT02679560 adverse events section.

Sponsor's own description

This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Liposomal Bupivacaine

Trials testing the same drug.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02679560.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing