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

Justin Parker Neurological Institute1 site in 1 country150 target enrollmentFebruary 2015

ConditionsDysphagia

Interventionsbupivacaine hydrochloride 0.5% solution 0.9% NaCl solution

Drugsbupivacaine hydrochloride 0.5% solution 0.9% NaCl solution

Overview

Phase: Not Applicable
Intervention: bupivacaine hydrochloride 0.5% solution
Conditions: Dysphagia
Sponsor: Justin Parker Neurological Institute
Enrollment: 150
Locations: 1
Primary Endpoint: Reduction in dysphagia scores
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

March 11, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Justin Parker Neurological Institute

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

bupivacaine hydrochloride 0.5% solution

Bupivacaine hydrochloride 0.5% 10 mL solution poured into the retropharyngeal space intraoperatively before wound closure during anterior cervical discectomy and fusion procedure

Intervention: bupivacaine hydrochloride 0.5% solution

0.9% NaCl solution

0.9% NaCl 10 mL solution poured into the retropharyngeal space intraoperatively before wound closureduring anterior cervical discectomy and fusion procedure

Intervention: 0.9% NaCl solution