DysphagiaNCT02376205
Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
A study testing bupivacaine hydrochloride 0.5% solution and 0.9% NaCl solution in people with Dysphagia, run by Justin Parker Neurological Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- bupivacaine hydrochloride 0.5% solution and 0.9% NaCl solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 11 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Boulder Neurosurgical Associates
Boulder, Colorado, 80303
About this study
Official title: The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
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.
Read the 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
- Being tested
- bupivacaine hydrochloride 0.5% solution, 0.9% NaCl solution
- Keywords
- Anterior Cervical Discectomy and Fusion, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine hydrochloride 0.5% solutionDrug
Also called Marcaine
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
0.9% NaCl solutionDrug
Also called Saline
10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 0.9% NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in dysphagia scores
Swallowing-Quality of Life Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Parker Neurological Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Mason, MD, Principal investigator, Boulder Neurosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376205
- Sponsor's protocol ID
- JPNI-4
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
- ClinicalTrials.gov ID
- NCT02376205
- Acronym / sponsor ID
- JPNI-4
- Conditions
- Dysphagia
- Keywords
- Anterior Cervical Discectomy and Fusion, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Justin Parker Neurological InstituteUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine hydrochloride 0.5% solution | Experimental | Drug: bupivacaine hydrochloride 0.5% solutionBupivacaine 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 solution | Placebo comparator | Drug: 0.9% NaCl solution0.9% NaCl 10 mL solution poured into the retropharyngeal space intraoperatively before wound closureduring anterior cervical discectomy and fusion procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine hydrochloride 0.5% solutionAlso: Marcaine10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure | Drug | bupivacaine hydrochloride 0.5% solution |
| 0.9% NaCl solutionAlso: Saline10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure | Drug | 0.9% NaCl solution |
Primary outcome
Reduction in dysphagia scores
Time frame: 3 months
Swallowing-Quality of Life Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Mason, MD principal investigator
Boulder Neurosurgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine hydrochloride 0.5% solution and 0.9% NaCl solution in people with Dysphagia, run by Justin Parker Neurological Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in dysphagia scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.