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Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery

NCT03318757 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-06-11

No results posted yet for this study

Summary

This research is being done to determine quantitative and qualitative differences in patients' post-operative pain levels following elective orthognathic surgery after the local administration of a liposomal bupivacaine injection.

A primary objective is to determine whether using a liposomal bupivacaine injection placed locally at the conclusion of elective orthognathic surgery will decrease pain levels (as determined by VAS scores). A secondary objective is to examine whether using a long acting liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery leads to decreased use of narcotics post-operatively.

Conditions

  • Orthognathic Surgery

Interventions

DRUG

Bupivacaine Extended Release Liposome Injection

Bupivacaine Extended Release Liposome Injection (Exparel TM) 133 mg diluted in 10ml of normal saline (13.3 mg/ml) will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.

DRUG

Bupivacaine HCl

10ml of Bupivacaine HCl 0.5% will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Pushkar Mehra, BDS DMD · BU Henry M. Goldman School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-12-31
Completion
2021-12-31
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 NCT03318757 on ClinicalTrials.gov