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 patient's quality of life, versus traditional bupivicaine alone.
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 patient's 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 week's experience regarding the topics of the questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
The primary objective is to examine differences in post-operative opioid consumption between the two groups.
Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.
Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.
Naval Medical Center San Diego
San Diego, California, United States
Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.
The primary objective is to examine differences in post-operative opioid consumption between the two groups
Time frame: Daily up to seven days post operative procedure.
Post-operative nausea and vomiting
Examine the number of times per day the participant experiences nausea and/or vomiting.
Time frame: Daily up to seven days post operative procedure.
Post-operative sleeping quality.
The Epworth Sleepiness Scale will be used to ascertain the quality of sleep. Eight situations are presented with the participant choosing the following responses: No chance of dozing = 0 Slight chance of dozing = 1 Moderate chance of dozing = 2 High chance of dozing = 3 The higher the combined score the poorer the quality of sleep.
Time frame: Daily up to seven days post operative procedure.
Post operative quality of life.
Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort. The higher the score means a better outcome.
Time frame: Daily up to seven days post operative procedure.
Post operative oral function.
Clinician will assess occlusion and midline symmetry on day of surgery post operative procedure and at one week post operative procedure clinic visit per standard of care with the aid of photographs using a millimeter ruler.
Time frame: Day of surgery and at seventh day post operative procedure.
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Post operative swelling.
Photos comparing cheek and lower jaw swelling with a millimeter ruler taken on day of surgery post operative procedure and one week post operative procedure clinic visit will be made by clinician per standard of care.
Time frame: Day of surgery and on post operative procedure day seven.