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

NCT03318757 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: H-36862
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bupivacaine liposomal injectable; post operative pain; post operative narcotic use; bupivacaine hydrochloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post operative narcotic use

  daily up to the 2 week post surgical visit

Study Arms (2)

Group 1- Bupivacaine extended release liposome injection

EXPERIMENTAL

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

Group 2- Bupivacaine HCl

ACTIVE COMPARATOR

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

Interventions

Bupivacaine Extended Release Liposome Injection DRUG

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.

Also known as: Exparel TM

Group 1- Bupivacaine extended release liposome injection

Bupivacaine HCl DRUG

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.

Also known as: Marcaine

Group 2- Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pregnancy
• known hypersensitivity to any local anesthetic

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pushkar Mehra, BDS DMD

  BU Henry M. Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 24, 2017
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)