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Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Primary Purpose

Dysphagia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

bupivacaine hydrochloride 0.5% solution

0.9% NaCl solution

About this trial

This is an interventional prevention trial for Dysphagia focused on measuring Anterior Cervical Discectomy and Fusion, Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Boulder Neurosurgical Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bupivacaine hydrochloride 0.5% solution

0.9% NaCl solution

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction in dysphagia scores

Swallowing-Quality of Life Questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT02376205

First Posted

February 17, 2015

Last Updated

February 11, 2020

Sponsor

Justin Parker Neurological Institute

1. Study Identification

Unique Protocol Identification Number

NCT02376205

Brief Title

Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

March 11, 2019 (Actual)

Study Completion Date

March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Justin Parker Neurological Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

Keywords

Anterior Cervical Discectomy and Fusion, Dysphagia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bupivacaine hydrochloride 0.5% solution

Arm Type

Experimental

Arm Description

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

Arm Title

0.9% NaCl solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

bupivacaine hydrochloride 0.5% solution

Other Intervention Name(s)

Marcaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% NaCl solution

Other Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction in dysphagia scores

Description

Swallowing-Quality of Life Questionnaire

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Mason, MD

Organizational Affiliation

Boulder Neurosurgical Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boulder Neurosurgical Associates

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80303

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

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