Exparel for Reducing Narcotics After Maxillary Orthognathic Surgery
This study aims to evaluate whether using Exparel can reduce the need for narcotics in adults after maxillary orthognathic surgery.
Liposomal bupivacaine
+ Bupivacain
+ Epinephrin
Neurologic Manifestations+4
+ Pain
+ Pain, Postoperative
Treatment Study
Summary
Study start date: February 28, 2018
Actual date on which the first participant was enrolled.This clinical trial explores the use of Exparel, a type of liposomal bupivacaine, in patients undergoing maxillary orthognathic surgery, a jaw surgery. The primary goal is to see if Exparel can reduce the need for opioids, which are strong painkillers that can have significant side effects and addiction potential, compared to the traditional use of bupivacaine alone. The study targets 100 individuals scheduled for this type of surgery and divides them into two groups: one receiving Exparel and the other receiving standard bupivacaine. This research is important because it could lead to better pain management options and improve recovery experiences, minimizing the risks associated with opioid use. Participants in the study will receive an injection of either 133 mg of Exparel or 50 mg of bupivacaine near the incision sites at the end of their surgery. All participants will have their anesthesia managed without opioids and will stay in the hospital for one night after the procedure for observation. Over the next week, participants will keep a daily diary to record their pain levels, quality of life factors like nausea and swelling, and any medications taken. After a week, they will return to the clinic to complete a questionnaire about their experience. This helps researchers determine how effective Exparel is in managing post-surgery pain and improving recovery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.86 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Naval Medical Center San Diego
San Diego, United StatesOpen Naval Medical Center San Diego in Google Maps