NCT02376205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

4.1 years

First QC Date

February 17, 2015

Last Update Submit

February 11, 2020

Conditions

Dysphagia

Keywords

Anterior Cervical Discectomy and FusionDysphagia

Outcome Measures

Primary Outcomes (1)

  • Reduction in dysphagia scores

    Swallowing-Quality of Life Questionnaire

    3 months

Study Arms (2)

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

Drug: bupivacaine hydrochloride 0.5% solution

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

Drug: 0.9% NaCl solution

Interventions

bupivacaine hydrochloride 0.5% solutionDRUG

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

Also known as: Marcaine
bupivacaine hydrochloride 0.5% solution
0.9% NaCl solutionDRUG

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

Also known as: Saline
0.9% NaCl solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boulder Neurosurgical Associates

Boulder, Colorado, 80303, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

BupivacaineSolutionsSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPharmaceutical PreparationsCrystalloid SolutionsIsotonic SolutionsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Alexander Mason, MD

    Boulder Neurosurgical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

US(1)