Clinical trial NCT02266797: Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
Official title: Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.

Detailed description: The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.

Eligibility criteria: Inclusion Criteria:

* The subjects included in the study are patients undergoing an anterior cervical spine procedure.

Exclusion Criteria:

* Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.

Primary outcomes:
measure: Intravenous Corticosteroids Effect on Post-operative Dysphagia
timeFrame: 12 months
measure: The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
timeFrame: 12 months
Secondary outcomes:
measure: The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
timeFrame: 12 months
measure: Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
timeFrame: Immediate post-operatively
measure: Examine the Impact of Dexamethasone on Radicular Pain.
timeFrame: 12 months
measure: Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Musculoskeletal Care (CMC)
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Westbury
country: United States
facility: NY Spine Institute
state: New York
Study officials:
References:
citation: Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7.
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: Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. doi: 10.1080/02688699550040882.
citation: Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. doi: 10.1001/archotol.127.1.51.
citation: Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. doi: 10.1007/pl00009513.