Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/21/2019 |
| Start Date: | May 2019 |
| End Date: | June 2020 |
| Contact: | Francesca Tesone, DMD |
| Email: | ftesone@bu.edu |
| Phone: | (617)-638-4350 |
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.
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.
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.
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.
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
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