Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

NCT ID: NCT02376205

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-03-11

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.

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

bupivacaine hydrochloride 0.5% solution

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

Group Type: EXPERIMENTAL

bupivacaine hydrochloride 0.5% solution

Intervention Type: DRUG

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

0.9% NaCl solution

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

Group Type: PLACEBO_COMPARATOR

0.9% NaCl solution

Intervention Type: DRUG

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

Interventions

bupivacaine hydrochloride 0.5% solution

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

Intervention Type: DRUG

0.9% NaCl solution

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

Intervention Type: DRUG

Other Intervention Names

Marcaine; Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Justin Parker Neurological Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Mason, MD

Role: PRINCIPAL_INVESTIGATOR

Boulder Neurosurgical Associates

Locations

Boulder Neurosurgical Associates

Boulder, Colorado, United States

Countries

United States

Other Identifiers

JPNI-4

Identifier Type: -

Identifier Source: org_study_id