Clinical trial NCT03318757: Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery
Official title: Does Bupivacaine Liposomal Injectable Suspension Decrease Post-operative Pain and Narcotic Use After Elective Orthognathic Surgery?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Orthognathic Surgery
Keywords: bupivacaine liposomal injectable
post operative pain
post operative narcotic use
bupivacaine hydrochloride
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Post operative pain
timeFrame: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, and 96 hours after surgery
Secondary outcomes:
measure: Post operative narcotic use
timeFrame: daily up to the 2 week post surgical visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: BU Henry M. Goldman School of Dental Medicine
name: Pushkar Mehra, BDS DMD
role: PRINCIPAL_INVESTIGATOR
References: