Dysphagia Clinical Trial
Official title:
The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
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 |
Verified date | February 2020 |
Source | Justin Parker Neurological Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boulder Neurosurgical Associates | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
Justin Parker Neurological Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in dysphagia scores | Swallowing-Quality of Life Questionnaire | 3 months |
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