Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Justin Parker Neurological Institute

Status: Completed

Conditions: Dysphagia

Treatments: Drug: 0.9% NaCl solution; Drug: bupivacaine hydrochloride 0.5% solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02376205

JPNI-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

bupivacaine hydrochloride 0.5% solution

Experimental group

Description:

Bupivacaine hydrochloride 0.5% 10 mL solution poured into the retropharyngeal space intraoperatively before wound closure during anterior cervical discectomy and fusion procedure

Treatment:

Drug: bupivacaine hydrochloride 0.5% solution

0.9% NaCl solution

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% NaCl solution