Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

Andrew Chung

Status: Unknown

Conditions: Postoperative Pain; Dysphagia; Dysphonia

Treatments: Drug: Racemic Epinephrine; Drug: Placebo (for racemic epinephrine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02724761

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Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Experimental: Racemic Epinephrine

Experimental group

Description:

Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine

Treatment:

Drug: Racemic Epinephrine

Placebo: 0.9% Normal Saline

Placebo Comparator group

Description:

0.5 mL 0.9% Normal Saline

Treatment:

Drug: Placebo (for racemic epinephrine)