Clinical trial NCT02724761: Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
Official title: Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Dysphonia
Postoperative Pain
Lead sponsor: Banner Health
Sponsor class: OTHER
Collaborators: name: More Foundation
name: Banner Health
First posted: 2016-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Dysphagia Numeric Rating Scale (DNRS)
timeFrame: 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).
measure: Change in Visual Analogue Scale (VAS) - Odynophagia
timeFrame: 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).
Secondary outcomes:
measure: Change in Rate of dysphonia
timeFrame: 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).
measure: Airway complication
timeFrame: Up to 1 month post-operatively
measure: Length of Stay
timeFrame: Up to 30 days post-operatively.
measure: Hospital Cost
timeFrame: Up to 30 days post-operatively.
measure: 30-day Hospital re-admission rates
timeFrame: Up to 30 days post-operatively.
measure: Number of emergency department visits per patient related to surgical complications of dysphagia or difficulty breathing
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: The CORE Institute, Banner University Medical Center
name: Norman Chutkan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalb S, Reis MT, Cowperthwaite MC, Fox DJ, Lefevre R, Theodore N, Papadopoulos SM, Sonntag VK. Dysphagia after anterior cervical spine surgery: incidence and risk factors. World Neurosurg. 2012 Jan;77(1):183-7. doi: 10.1016/j.wneu.2011.07.004. Epub 2011 Nov 15.
citation: Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
citation: Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
citation: Singh K, Marquez-Lara A, Nandyala SV, Patel AA, Fineberg SJ. Incidence and risk factors for dysphagia after anterior cervical fusion. Spine (Phila Pa 1976). 2013 Oct 1;38(21):1820-5. doi: 10.1097/BRS.0b013e3182a3dbda.
citation: Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.
citation: Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.
citation: Song KJ, Lee SK, Ko JH, Yoo MJ, Kim DY, Lee KB. The clinical efficacy of short-term steroid treatment in multilevel anterior cervical arthrodesis. Spine J. 2014 Dec 1;14(12):2954-8. doi: 10.1016/j.spinee.2014.06.005. Epub 2014 Jun 12.
citation: Plint AC, Osmond MH, Klassen TP. The efficacy of nebulized racemic epinephrine in children with acute asthma: a randomized, double-blind trial. Acad Emerg Med. 2000 Oct;7(10):1097-103. doi: 10.1111/j.1553-2712.2000.tb01258.x.
citation: Langley JM, Smith MB, LeBlanc JC, Joudrey H, Ojah CR, Pianosi P. Racemic epinephrine compared to salbutamol in hospitalized young children with bronchiolitis; a randomized controlled clinical trial [ISRCTN46561076]. BMC Pediatr. 2005 May 5;5(1):7. doi: 10.1186/1471-2431-5-7.