Effect of a Pre-Operative Local Anesthetic Facial Block on Post-Operative Rhinoplasty Pain
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 15 - 89 |
| Updated: | 11/2/2018 |
| Start Date: | December 2018 |
| End Date: | November 2020 |
| Contact: | Linda Lee, MD |
| Email: | linda_lee@meei.harvard.edu |
| Phone: | 617-573-3709 |
The specific aim of this study is to determine whether pre-operative treatment with a
bupivacaine nerve block can influence post-operative pain and oxycodone usage among
rhinoplasty patients. Specifically, we plan to directly compare the reported pain scale,
nausea, and oxycodone usage among patients who received the bupivacaine block against those
of patients in the saline control condition. These assessments will be documented on day 0
(day of operation) by a nurse in the Post-Anesthesia Care Unit, while the same data points
will be collected over the phone by our clinical research coordinator on post-operative days
1, 2 , 3, and 8 following discharge.
bupivacaine nerve block can influence post-operative pain and oxycodone usage among
rhinoplasty patients. Specifically, we plan to directly compare the reported pain scale,
nausea, and oxycodone usage among patients who received the bupivacaine block against those
of patients in the saline control condition. These assessments will be documented on day 0
(day of operation) by a nurse in the Post-Anesthesia Care Unit, while the same data points
will be collected over the phone by our clinical research coordinator on post-operative days
1, 2 , 3, and 8 following discharge.
The proposed study is a prospective longitudinal study that classifies as a randomized
double-blind placebo control study given that patients are randomly allocated to either the
group receiving the treatment under investigation (experimental group, receiving bupivacaine
as outlined below) or to a control group (receiving a saline control injection). In this
study, patients, study physicians, and research coordinator (study team) will be blinded as
to which treatment group each patient is assigned given that the pharmacy will manage the
randomization process. Moreover, this study constitutes a phase IV clinical trial because we
are studying a drug that has already been approved by the FDA. We are looking at quantifying
the effect of a local anesthetic, bupivacaine, on post-operative pain following rhinoplasty.
In this study, we are using the drug for its stated clinical purpose - as a local anesthetic.
In this way, this study does not constitute a phase I, II, or III clinical trial.
For this study, we plan to enroll Mass. Eye and Ear patients who present for cosmetic and/or
functional rhinoplasty. Each qualifying patient will be presented with the study and
consented should they choose to enroll. This study will consist of two arms; patients will be
randomly assigned to one of two groups - either the experimental group, where patients
receive an injection of bupivacaine to the infraorbital nerve, or a control group in which
patients are injected with a saline solution to the same region.
A standardized pre-operative protocol will be followed to ensure that all patients receive
standard of care. After each patient undergoes the surgical rhinoplasty procedure, they will
be asked to report their pain scale, level of nausea, and use of oxycodone on day 0 (the day
of the surgical operation). On day 0, a nurse in the Post-Anesthesia Care Unit will collect
the aforementioned data points approximately once every hour and record them in Epic as part
of standard protocol.
On post-operative days 1, 2, 3, and 8, a trained research coordinator will call each patient
and use a standardized phone script to assess the same data points - pain scale, nausea, and
use of oxycodone, as well as lip numbness at time of surgery (collected only at
post-operative day 1). Taken together, this data will help establish whether a pre-operative
local anesthetic facial block can improve post-operative pain and opioid usage among
rhinoplasty patients. We plan to enroll 20 patients at MEEI in each arm of the study (40
patients total), among patients already scheduled to undergo a rhinoplasty procedure for
cosmetic and/or functional reasons.
double-blind placebo control study given that patients are randomly allocated to either the
group receiving the treatment under investigation (experimental group, receiving bupivacaine
as outlined below) or to a control group (receiving a saline control injection). In this
study, patients, study physicians, and research coordinator (study team) will be blinded as
to which treatment group each patient is assigned given that the pharmacy will manage the
randomization process. Moreover, this study constitutes a phase IV clinical trial because we
are studying a drug that has already been approved by the FDA. We are looking at quantifying
the effect of a local anesthetic, bupivacaine, on post-operative pain following rhinoplasty.
In this study, we are using the drug for its stated clinical purpose - as a local anesthetic.
In this way, this study does not constitute a phase I, II, or III clinical trial.
For this study, we plan to enroll Mass. Eye and Ear patients who present for cosmetic and/or
functional rhinoplasty. Each qualifying patient will be presented with the study and
consented should they choose to enroll. This study will consist of two arms; patients will be
randomly assigned to one of two groups - either the experimental group, where patients
receive an injection of bupivacaine to the infraorbital nerve, or a control group in which
patients are injected with a saline solution to the same region.
A standardized pre-operative protocol will be followed to ensure that all patients receive
standard of care. After each patient undergoes the surgical rhinoplasty procedure, they will
be asked to report their pain scale, level of nausea, and use of oxycodone on day 0 (the day
of the surgical operation). On day 0, a nurse in the Post-Anesthesia Care Unit will collect
the aforementioned data points approximately once every hour and record them in Epic as part
of standard protocol.
On post-operative days 1, 2, 3, and 8, a trained research coordinator will call each patient
and use a standardized phone script to assess the same data points - pain scale, nausea, and
use of oxycodone, as well as lip numbness at time of surgery (collected only at
post-operative day 1). Taken together, this data will help establish whether a pre-operative
local anesthetic facial block can improve post-operative pain and opioid usage among
rhinoplasty patients. We plan to enroll 20 patients at MEEI in each arm of the study (40
patients total), among patients already scheduled to undergo a rhinoplasty procedure for
cosmetic and/or functional reasons.
Inclusion Criteria:
- Patients undergoing a rhinoplasty procedure for cosmetic and/or functional reasons
- Patients between the ages of 15 and 89
Exclusion Criteria:
- Patients on chronic opioids for any pain syndrome pre-operatively
- Non-English speaking patients
- Patients who are younger than 15 years of age and older than 89 years of age
- Patients not undergoing rhinoplasty
- Patients who are allergic to bupivacaine or related anesthteics
- Patients who are pregnant
We found this trial at
1
site
Click here to add this to my saved trials
