Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Drug: bupivacaine hydrochloride 0.5% solution; Drug: 0.9% NaCl solution

• Registration Number: NCT02376205
• Lead Sponsor: Justin Parker Neurological Institute

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Primary Completion: 2019-03-11
• Study Completion: 2019-03-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
bupivacaine hydrochloride 0.5% solution	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
0.9% NaCl 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

Primary Outcome Measures

Name	Time	Method
Reduction in dysphagia scores	3 months	Swallowing-Quality of Life Questionnaire

Trial Locations

Locations (1)

Boulder Neurosurgical Associates; 🇺🇸 Boulder, Colorado, United States