An interventional study of bupivacaine hydrochloride 0.5% solution and 0.9% NaCl solution in Dysphagia, sponsored by Justin Parker Neurological Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Justin Parker Neurological Institute · Not applicable, Interventional, and Prevention
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Justin Parker Neurological Institute is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
Also known as: Marcaine
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
Also known as: Saline
Reduction in dysphagia scores
Swallowing-Quality of Life Questionnaire
Time frame: 3 months
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Justin Parker Neurological Institute