The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty

NCT04377204 | Completed Early Phase 1 FDA Drug

• 1 other identifier: OurLadyLH
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Local Anesthetic

Keywords

rhinoplasty; bupivacaine; pain management

Outcome Measures

Primary Outcomes (1)

• Number and frequency of Pain pills taken up to 1 week post-op

  Patients will record the frequency and number of oxycodone pills taken for pain up to 7 days post-op

  7 days post-operatively

Secondary Outcomes (1)

• Pain scores up to 24 hrs post-operatively

  24 hours

Study Arms (2)

Lidocaine Group

ACTIVE COMPARATOR

Local injection of 1% lidocaine with 1:100,000 epinephrine one time pre-operatively prior to general anesthesia

Drug: Lidocaine

Lidocaine with Bupivacaine

ACTIVE COMPARATOR

Local injection of 1% lidocaine with 1:100,000 epinephrine mixed 1:1 with 0.5% marcaine bupivacaine with 1:200,000 epinephrine, one time pre-operatively prior to general anesthesia

Drug: marcaine bupivacaine

Interventions

marcaine bupivacaine DRUG

This drug is already FDA approved and used for the indication as a local anesthetic. The study herein would like to examine the pain outcomes of enrolled patients who will either have lidocaine alone OR lidocaine+bupivacaine combination locally prior to rhinoplasty surgery.

Lidocaine with Bupivacaine

Lidocaine DRUG

This drug is already FDA approved and used for the indication as a local anesthetic. The study herein would like to examine the pain outcomes of enrolled patients who will either have lidocaine alone OR lidocaine+bupivacaine combination locally prior to rhinoplasty surgery.

Lidocaine Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18 and over
• undergoing external rhinoplasty

You may not qualify if:

• 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)

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Justin C Sowder, MD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be consented to participate, but will be blinded to which preoperative local anesthetic regimen they will receive for their rhinoplasty procedure.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Director

Model Details: Single blinded cohort intervention

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)