Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Conditions
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Dysphagia

Intervention / Treatment
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* Drug: bupivacaine hydrochloride 0.5% solution
* Drug: 0.9% NaCl solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine hydrochloride 0.5% solution<br>Bupivacaine hydrochloride 0.5% 10 mL solution poured into the retropharyngeal space intraoperatively before wound closure during anterior cervical discectomy and fusion procedure | Drug: bupivacaine hydrochloride 0.5% solution<br>* 10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure<br>* Other names: Marcaine;|
| Placebo Comparator: 0.9% NaCl solution<br>0.9% NaCl 10 mL solution poured into the retropharyngeal space intraoperatively before wound closureduring anterior cervical discectomy and fusion procedure | Drug: 0.9% NaCl solution<br>* 10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in dysphagia scores | Swallowing-Quality of Life Questionnaire | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cervical Discectomy and Fusion, Dysphagia