Orthognathic Surgery Clinical Trial
Official title:
Does Bupivacaine Liposomal Injectable Suspension Decrease Post-operative Pain and Narcotic Use After Elective Orthognathic Surgery?
Verified date | June 2020 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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