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

NCT ID: NCT03318757

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Orthognathic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine Extended Release Liposome Injection

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Exparel TM; Marcaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pushkar Mehra, BDS DMD

Role: PRINCIPAL_INVESTIGATOR

BU Henry M. Goldman School of Dental Medicine

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-36862

Identifier Type: -

Identifier Source: org_study_id