The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty
Condition: Pain, Postoperative; Local Anesthetic
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): marcaine bupivacaine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded cohort intervention
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: rhinoplasty; bupivacaine; pain management