Trial | NCT02376205  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 Started
Feb 28
2015
Primary Completion
Mar 11
2019
Study Completion
Mar 11
2019
Last Update
Feb 13
2020

Drug bupivacaine hydrochloride 0.5% solution

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

  • Other names: Marcaine

Drug 0.9% NaCl solution

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

  • Other names: Saline

bupivacaine hydrochloride 0.5% solution Experimental

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 Placebo Comparator

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

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
No Results Posted