The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty: A Multi-institutional, Randomized, Single Blinded Clinical Trial

OurLadyLH

On average, more than 130 Americans die every day from opioid overdose. Surgeons provide 37% of all opioid prescriptions in the United states, second only behind pain management physicians. A recent report found that patients who receive a 5-day supply of opioid medication have a 10% chance of using opioids 12 months later. Additionally, studies have shown that many opioid abusers are not the intended recipient, with over half diverting them from friends and family. Rhinoplasty is one of the most common procedures performed by facial plastic surgeons, with over 215,000 performed in the United States in 2017. Patients undergoing nasal surgery have been shown to be at significant risk for persistent and prolonged opioid use after filling an opioid prescription in the perioperative period. Thus, the management of postoperative pain without contributing to the opioid epidemic is a imperative. The first three days following nasal surgery are generally associated with considerable pain, with the highest levels occuring within the initial 24 hours. Published studies have demonstrated the benefit of non-opioid medications following rhinoplasty, such as pregabalin and celecoxib. There has also been growing recognition of the benefits of "pre-emptive analgesia," such as the use of local anesthesia, which not only helps control pain, but in turn decreases the anxiety caused by pain and can prevent patient turning to narcotics to break the cycle. These studies have predominantly focused on the immediate postoperative period, e.g. the first 24 hours. Currently, many surgeons use lidocaine with 1% epinephrine as local anesthesia for rhinoplasty due to its widespread availability, rapid time to onset, and safety profile. Several studies have shown the benefit of Marcaine bupivacaine over lidocaine for pain control and opioid consumption during the first 24 hours after surgery. This is not surprising, as the half-life of lidocaine is approximately 90 minutes in a healthy individual, compared to 160 minutes for Marcaine bupivacaine. However, there are no studies to date that have evaluated the effect that long-acting local anesthesia has on post-operative opioid consumption past the first 24 hours after surgery. Our study aims to compare total postoperative opioid use for patients who received lidocaine as local anesthesia at the time of surgery versus a mixture of lidocaine and Marcaine bupivacaine.

2020-06-01

2022-12-31

2022-12-31

Completed

Early phase I

5

Inclusion Criteria: * ages 18 and over * undergoing external rhinoplasty Exclusion Criteria: * Pre-existing chronic pain within 30 days prior to surgery * Opioid use within 30 days before their surgery * Patients undergoing a concurrent procedure (i.e. facial rejuvenation)

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blinded cohort intervention', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will be consented to participate, but will be blinded to which preoperative local anesthetic regimen they will receive for their rhinoplasty procedure.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2023-03-23