Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499181
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-04
Brief Title:
Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
Can Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patients quality of life versus traditional bupivicaine alone
Detailed Description:
A prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patients quality of life versus traditional bupivicaine alone A total of 100 patients who would ordinarily undergo maxillary orthognathic procedures will be randomized into 2 groups One group will receive 133mg of Exparel must limit volume of product due to spaces involved and other studies in oral surgery have used 133mg at the completion of the procedure while the control group receives 50 mg of bupivicaine at the completion of the procedure as is typical standard of care The injections will be made in similar regions near the incision lines No other differences will be made between the groups Perioperative anesthesia will consist of non-opioid techniques and patients will be monitored post-operatively during a 1 night hospital admission Patients will complete an anonymous daily diary for 7 days The diary will consist of information regarding pain scores quality of life nausea swelling oral function etc and medicines taken
At one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous weeks experience regarding the topics of the questionnaires
At one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous weeks experience regarding the topics of the questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None