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Local Anesthetic
Liposomal bupivicaine with nerve block for Postoperative Pain
Phase 4
Waitlist Available
Led By Kristopher Day, MD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 48 hours after surgery
Awards & highlights
Study Summary
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 48 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 48 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Jaw
Secondary outcome measures
Oral intake
Pain Scores
Total morphine-equivalents
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liposomal bupivicaine with nerve blockExperimental Treatment2 Interventions
The treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block.
Group II: Nerve block onlyPlacebo Group1 Intervention
The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
348 Previous Clinical Trials
80,297 Total Patients Enrolled
Kristopher Day, MDPrincipal InvestigatorDell Children's Medical Center of Central Texas
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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