Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Justin Parker Neurological Institute150 enrolled

Overview

The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion.

The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group. These solutions will be poured into the retropharyngeal space intraoperatively before wound closure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Dysphagia

Interventions

bupivacaine hydrochloride 0.5% solutionDRUG

10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure

0.9% NaCl solutionDRUG

10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 y.o. * Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms * Patients are wiling and able to sign informed consent and complete questionnaires Exclusion Criteria: * More than 2-level ACDF surgeries * Previous cervical spine surgery * Surgeries for trauma, infection or tumor * Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine) * Known history of swallowing issues (e.g. dysphagia, odynophagia) * Pregnant or breastfeeding

Locations (1)

Boulder Neurosurgical Associates

Boulder, Colorado, United States

Outcomes

Primary Outcomes

Reduction in dysphagia scores

Swallowing-Quality of Life Questionnaire

Time frame: 3 months

Data from ClinicalTrials.gov

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