Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

Not Applicable

• Conditions: Dysphonia; Postoperative Pain; Dysphagia
• Interventions: Drug: Placebo (for racemic epinephrine); Drug: Racemic Epinephrine

• Registration Number: NCT02724761
• Lead Sponsor: Andrew Chung

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31
• Study Start: 2016-09
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: 0.9% Normal Saline	Placebo (for racemic epinephrine)	0.5 mL 0.9% Normal Saline
Experimental: Racemic Epinephrine	Racemic Epinephrine	Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine

Primary Outcome Measures

Name	Time	Method
Change in Dysphagia Numeric Rating Scale (DNRS)	Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).	It is a simple questionnaire that is a functional assessment of dysphagia i.e. difficulty swallowing solids, liquids, etc. Additionally, asks a simple "yes" and "no" question for the presence of dysphagia.
Change in Visual Analogue Scale (VAS) - Odynophagia	Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).	It is a simple self-reported pain intensity scale from 0-10 with 0 being no pain, and 10 being the worst pain possible as it relates to swallowing.

Secondary Outcome Measures

Name	Time	Method
Change in Rate of dysphonia	Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).	Patients will be asked to answer whether or not they are experiencing dysphonia with a simple "yes" or "no".
Airway complication	Up to 1 month post-operatively	Any airway complication related to post-operative swelling that requires intubation will be retrospectively recorded off of hospital records. This will be recorded as the number of patients requiring intubation. This number will be reported in any future presentation of data.
Length of Stay	Up to 30 days post-operatively.	Length of hospital stay following surgery
Hospital Cost	Up to 30 days post-operatively.	Will determine any additional cost of care associated with dysphagia, dysphonia, airway complications. This will include any emergency department visits or hospital re-admissions directly related to these post-operative complications.
30-day Hospital re-admission rates	Up to 30 days post-operatively.	any re-admission in the first 30 days following surgery specifically due to dysphagia, dysphonia, or airway complications related to surgery.
Number of emergency department visits per patient related to surgical complications of dysphagia or difficulty breathing	30 days	Number of emergency department visits in the first 30 days following surgery with patient complaint of "difficulty or pain with swallowing" or "difficulty breathing" as direct complications of surgery (i.e. secondary to post-operative swelling, hematoma formation). Patient charts will be retrospectively reviewed 30 days post-operatively.

Trial Locations

Locations (1)

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States