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Extended Delivery of Bupivacaine Study in Herniorrhaphy

NCT04102267 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-09-26

No results posted yet for this study

Summary

This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.

Conditions

  • Analgesia

Interventions

DRUG

Bupivacaine liposome injectable suspension

Liposomal bupivacaine 266 mg via injection

DRUG

Bupivacaine HCl without epinephrine via continuous infusion

Bupivacaine HCl 300 mg via continuous infusion

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2018-09-03
Completion
2018-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102267 on ClinicalTrials.gov