Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2016 |
| End Date: | September 2018 |
| Contact: | Andrew S Chung, DO |
| Email: | andrew.chung@bannerhealth.com |
| Phone: | 4049381687 |
Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial
Our double-blinded, randomized control trial will assess the effect of nebulized racemic
epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.
The investigators have had success in managing post-operative dysphagia in patients
undergoing ACDF with the administration of this drug. Half of the participants will review
nebulized epinephrine. The other half will receive placebo.
epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.
The investigators have had success in managing post-operative dysphagia in patients
undergoing ACDF with the administration of this drug. Half of the participants will review
nebulized epinephrine. The other half will receive placebo.
Based on data from the National Inpatient Sample from 2002-2012, patients undergoing
elective primary ACDF, diagnosed with dysphagia (4% of total patients), had a two-fold
increase in mean length of stay (4.03 compared to 1.56 days; p < 0.001) and a substantial
increase in their total hospital charges (p < 0.001) versus those not diagnosed with
dysphagia. There are very few level I studies which describe successful management of these
complications. Steroids have shown promise, however, there exist concerns for consequent
delayed bony fusion. Racemic epinephrine is a mixture of both the R and L isomers of
epinephrine which theoretically results in a milder side effect profile and longer
shelf-life versus the standard L-epinephrine. Traditionally, racemic epinephrine has been
administered in a nebulized form for the treatment of severe asthma, laryngeal edema, and
bronchiolitis. The most severe side effects that have been reported include tachyarrhythmias
and paradoxical bronchospasms, although these reports are rare and limited mainly to single
case reports or case series. It confers its therapeutic effect through Racemic α-adrenergic
and β-adrenergic mediated vasoconstriction of mucosal vasculature decreasing edema and in
the respiratory tract, inducing bronchodilation. The PI, has been utilizing nebulized
racemic epinephrine at standard dosages (1 unit of 0.5 ml of 2.25% racemic epinephrine) for
the treatment of severe post-operative dysphagia in patients undergoing ACDF for 20 years.
The investigator has achieved marked success with this intervention with no notable
associated complications. Despite being successfully utilized in this manner for many years
in small pockets of the spine community, the use of prophylactic racemic epinephrine for the
management of dysphagia has not been described in the literature. The investigators hope to
be able to fill this important knowledge-gap with our study data.
elective primary ACDF, diagnosed with dysphagia (4% of total patients), had a two-fold
increase in mean length of stay (4.03 compared to 1.56 days; p < 0.001) and a substantial
increase in their total hospital charges (p < 0.001) versus those not diagnosed with
dysphagia. There are very few level I studies which describe successful management of these
complications. Steroids have shown promise, however, there exist concerns for consequent
delayed bony fusion. Racemic epinephrine is a mixture of both the R and L isomers of
epinephrine which theoretically results in a milder side effect profile and longer
shelf-life versus the standard L-epinephrine. Traditionally, racemic epinephrine has been
administered in a nebulized form for the treatment of severe asthma, laryngeal edema, and
bronchiolitis. The most severe side effects that have been reported include tachyarrhythmias
and paradoxical bronchospasms, although these reports are rare and limited mainly to single
case reports or case series. It confers its therapeutic effect through Racemic α-adrenergic
and β-adrenergic mediated vasoconstriction of mucosal vasculature decreasing edema and in
the respiratory tract, inducing bronchodilation. The PI, has been utilizing nebulized
racemic epinephrine at standard dosages (1 unit of 0.5 ml of 2.25% racemic epinephrine) for
the treatment of severe post-operative dysphagia in patients undergoing ACDF for 20 years.
The investigator has achieved marked success with this intervention with no notable
associated complications. Despite being successfully utilized in this manner for many years
in small pockets of the spine community, the use of prophylactic racemic epinephrine for the
management of dysphagia has not been described in the literature. The investigators hope to
be able to fill this important knowledge-gap with our study data.
Inclusion Criteria:
1. Patients > 18 years of age
2. Primary two and three-level ACDF between C3-7
3. Approved pre-authorization to undergo the procedure
Exclusion Criteria:
1. Patients < 18 years of age
2. Patients who are unable to give their own consent
3. Revision ACDF
4. Combined anterior-posterior surgeries
5. Surgeries involving C2-C3 or C7-T1
6. Surgeries related to trauma, infection, or tumor
7. Patients with baseline swallowing dysfunction
8. Patients currently on steroids
9. Patients with severe cardiac disease
10. Uncontrolled diabetics as defined by patients with a HbA1C > 8%
11. Patients with known allergy to epinephrine
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