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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376205

Enrollment

150

Registered

2015-03-03

Start date

2015-02-28

Completion date

2019-03-11

Last updated

2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Anterior Cervical Discectomy and Fusion, Dysphagia

Brief 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.

Detailed 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.

Interventions

DRUGbupivacaine hydrochloride 0.5% solution

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

DRUG0.9% NaCl solution

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in dysphagia scores	3 months	Swallowing-Quality of Life Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026