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

Does Bupivacaine Liposomal Injectable Suspension Decrease Post-operative Pain and Narcotic Use After Elective Orthognathic Surgery?

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.

Study Overview

• Status: Withdrawn
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Drug: Bupivacaine Extended Release Liposome Injection; Drug: Bupivacaine HCl

Detailed Description

Participants in Group 1 (study group) will receive ExparelTM (133 mg/10 ml - 4 ml into the maxilla, and 6 ml into the mandible). This will be injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure. Participants in Group 2 (standard of care) will receive bupivacaine 0.5% (4 ml into the maxilla, and 6 ml into the mandible) injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure.

Post-operatively, all participants will be cared for utilizing the current standard post-operative pain management protocol for all patients undergoing elective orthognathic surgery at Boston Medical Center. This consists of acetaminophen 325 mg given every 4 hours as a scheduled medication; patients also receive an additional 325 mg of acetaminophen for a reported pain level of 1-3, 5 mg of oxycodone for a reported pain level of 4-6, and 10 mg of oxycodone for a reported pain level of 7-10. All participants will be provided the same methods of postoperative pain control following their elective orthognathic surgery.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• males and females 18-40 years of age undergoing elective double jaw orthognathic surgery

Exclusion Criteria:

• pregnancy
• known hypersensitivity to any local anesthetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1- Bupivacaine extended release liposome injection; Bupivacaine extended release liposome injection (Exparel TM) is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.	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.; Other Names: Exparel TM
ACTIVE_COMPARATOR: Group 2- Bupivacaine HCl; Bupivacaine HCl (Marcaine) is a local anesthetic that reduces the flow of sodium in and out of nerves which decreases the initiation and transfer of nerve signals in the area in which the drug is applied.	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.; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post operative pain	After surgery, participants will document in a pain journal what their pain level is based on a smiley face visual analog scale (VAS) from 0-10, where 0='no pain' and 10='worst possible, unbearable, excruciating pain'. They will rate their pain using the VAS 14 times - every 4 hours the first 48 hours and then at 72 and 96 hours post surgery. Higher scores are associated with more severe pain. The participant will return the pain journal at their post operative assessment visit.	4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, and 96 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative narcotic use	The time and dosage of narcotics used in the postoperative period will be documented in the participants' medical record records while hospitalized and documented in the participants' pain journal once discharged. The data from the medical records and pain journal will be used to assess total narcotic pain use.	daily up to the 2 week post surgical visit

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Pushkar Mehra, BDS DMD, BU Henry M. Goldman School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: post operative pain; bupivacaine liposomal injectable; post operative narcotic use; bupivacaine hydrochloride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: H-36862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes