Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04377204 |
| Other study ID # |
OurLadyLH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Our Lady of the Lake Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
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