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

NCT ID: NCT04377204

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

The local anesthesia regimen administered prior to surgery is a standard practice for rhinoplasty procedures. However, there is variation in the kind of anesthetic utilized during this time. In our practice, we have used different combinations along with epinephrine which include lidocaine or lidocaine with Marcaine bupivacaine dilutions. Although both are effective at pre-operative local numbing, investigators have seen less reported pain outcomes as perceived by the patient feedback. Therefore, investigators aim to identify specifically the usage of post-operative pain medication with those who had an epinephrine/lidocaine local anesthetic vs. those who had the epi/lidocaine/bupivacaine combination. Patients will be informed about the study and consented for participation. They will be randomized pre-operatively by permuted block assignment to the control treatment (1% lidocaine with 1:100,000 epinephrine) or the study treatment (1% lidocaine with 1:100,000 epinephrine mixed 1:1 with 0.5% Marcaine bupivacaine with 1:200,000 epinephrine) using a predetermined weight-calculated maximum dosage that would be safe for injection of either anesthesia.

As per standard procedure, the patients will be premedicated with a standardized dose of versed if determined necessary by anesthesia. Anesthesia will be induced utilizing weight based dosing of propofol and rocuronium. Intraoperative anesthesia will be maintained utilizing total intravenous anesthesia (propofol, fentanyl/remifentanyl doses). All patients will be given antibiotics (weight based dosing, Ancef or Clindamycin) and 8mg of dexamethasone prior to skin incision. Once anesthesia has been induced, the nose will be injected with local anesthesia as follows: transcutaneous to the bilateral dorsal nasal and the angular neurovascular bundles, transcutaneously along the columella and nasal dorsum, transnasally along the nasal dorsum and ala, the bilateral nasal septum, and the inferior turbinates with a total dose of 10ml's. Topical decongestion and anesthesia will then be obtained with 3 x 0.5cm cottonoids soaked with 4% cocaine placed bilaterally. A standard external rhinoplasty approach will the be performed, and grafting done as necessary. At then end of the procedure, Doyle nasal septal splints will be placed (Reuter-Bivalves if alar grafting performed).

In the immediate post-operative period, pain will be controlled with short acting analgesics (standardized regimen for all patients to be decided with anesthesia team) while in the acute care setting and recorded again as per standard of care. Once discharged from acute care, the patient will be given instructions to control their pain with acetaminophen (1000mg every 8 hours) scheduled during the first 72 hours, then as needed thereafter. They will also be given a prescription for oxycodone (15 tablets) with instruction to take 5mg every 6 hours as needed for breakthrough pain. They will be provided a pain diary for the first 24 hours to record their pain using the Faces scale (ranging 1-10 with 1 being no pain up to 10 being the worst pain ever experienced) at the 1, 2, 4, 6, 12, and 24 hours marks after discharge from surgery. Additionally, they will be asked to keep track of how many pain medications (oxycodone) they took over the first week after surgery. Their pain scores and amount of medication utilized will be recorded upon their follow up visit to the clinic.

Conditions

Pain, Postoperative; Local Anesthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lidocaine Group

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

marcaine bupivacaine

Intervention Type: 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.

Interventions

marcaine bupivacaine

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.

Intervention Type: DRUG

Lidocaine

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: collaborator

Our Lady of the Lake Hospital

OTHER

Sponsor Role: lead

Responsible Party

Leslie Son

Academic Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin C Sowder, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center - New Orleans

Locations

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

OurLadyLH

Identifier Type: -

Identifier Source: org_study_id