Pain, PostoperativeEarly Phase 1NCT04377204
The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty
A Early Phase 1 study testing marcaine bupivacaine and Lidocaine in people with Pain, Postoperative and Local Anesthetic, run by Our Lady of the Lake Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Local Anesthetic
- What is being tested?
- marcaine bupivacaine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18 and over
- undergoing external rhinoplasty
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808
About this study
Official title: The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty: A Multi-institutional, Randomized, Single Blinded Clinical Trial
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.
Read more
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.
Read the 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
- Being tested
- marcaine bupivacaine, Lidocaine
- Keywords
- rhinoplasty, bupivacaine, pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marcaine bupivacaineDrug
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.
LidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Active comparator | Local injection of 1% lidocaine with 1:100,000 epinephrine one time pre-operatively prior to general anesthesia Receives: 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 Receives: Drug: marcaine bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days post-operatively
Secondary outcomes (1)
Pain scores up to 24 hrs post-operatively
Patients will be asked to maintain a pain diary to record their pain on a FACES scale at 1, 2, 4, 6, 12 and 24hrs post-operatively. The pain scale will be from 1-10 with 1 indicating no pain present up to a maximum score of 10 indicating the worst pain they've ever felt.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded cohort intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Leslie Son, Our Lady of the Lake Hospital
- Investigators
- Justin C Sowder, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377204
- Sponsor's protocol ID
- OurLadyLH
- Status last verified
- Mar 2023
- First submitted
- 4 May 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty: A Multi-institutional, Randomized, Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04377204
- Acronym / sponsor ID
- OurLadyLH
- Conditions
- Pain, Postoperative, Local Anesthetic
- Keywords
- rhinoplasty, bupivacaine, pain management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded cohort intervention
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Active comparator | Drug: LidocaineLocal injection of 1% lidocaine with 1:100,000 epinephrine one time pre-operatively prior to general anesthesia |
| Lidocaine with Bupivacaine | Active comparator | Drug: marcaine bupivacaineLocal 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages 18 and over
- undergoing external rhinoplasty
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| marcaine bupivacaineThis 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. | Drug | Lidocaine with Bupivacaine |
| LidocaineThis 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. | Drug | Lidocaine Group |
Primary outcome
Number and frequency of Pain pills taken up to 1 week post-op
Time frame: 7 days post-operatively
Patients will record the frequency and number of oxycodone pills taken for pain up to 7 days post-op
1 secondary outcome
Pain scores up to 24 hrs post-operatively
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin C Sowder, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing marcaine bupivacaine and Lidocaine in people with Pain, Postoperative and Local Anesthetic, run by Our Lady of the Lake Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and frequency of Pain pills taken up to 1 week post-op (time frame: 7 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.