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OpenTrials
Completed

NCT Number: NCT02376205

Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boulder Neurosurgical Associates

Boulder, Colorado, 80303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupivacaine hydrochloride 0.5% solution

Drug

10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure

Other names: Marcaine

0.9% NaCl solution

Drug

10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure

Other names: Saline

Primary outcomes

  1. Reduction in dysphagia scores

    Time frame: 3 months

    Swallowing-Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

Justin Parker Neurological Institute

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2015
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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