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NCT02376205 Clinical Trial

Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02376205
Other study ID # JPNI-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date March 11, 2019

Study information
Verified date February 2020
Source Justin Parker Neurological Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date March 11, 2019
Est. primary completion date March 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• bupivacaine hydrochloride 0.5% solution
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
• 0.9% NaCl solution
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure

Locations
Country Name City State
United States Boulder Neurosurgical Associates Boulder Colorado

Sponsors (1)
Lead Sponsor Collaborator
Justin Parker Neurological Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in dysphagia scores Swallowing-Quality of Life Questionnaire 3 months
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