Anesthesia, Pediatrics, SurgeryPhase 4NCT02724033
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
A Phase 4 study testing regional nerve block and Antiemetic in people with Anesthesia, Pediatrics, Surgery, run by Indiana University at 1 site in United States.
Trial summary
The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Anesthesia, Pediatrics, Surgery
- What is being tested?
- regional nerve block and Antiemetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient Age 1-18 yo
- Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
- Past history of PONV susceptibility
Who cannot join
- Patient/ Parents refusal
- Infection at the site of local anesthetic injection
- Known coagulopathy
- Existing VP shunt
- Severe mental disability
- Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block With Intravenous Antiemetic Drugs Dexamethasone and Ondansetron and Incidence of Post-operative Nausea Vomiting for Inner Ear Surgery
The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored.
The rational is based on the knowledge of the anatomical innervation of the inner ear and the role of the parasympathetic nervous system in the emetic act. A lot of focus has been given on its counterpart the sympathetic nervous system and its role in painful conditions. The investigators believe that the nerve blockade of the parasympathetic innervation can have some beneficial effect in the post-surgical patient.
Read the detailed description
The researchers hypothesize another potential antiemetic mechanism by the blockade of the auricular branch of the vagus nerve at the ear canal (commonly described as nerve of Arnold) in conjunction with a block of the greater auricular nerve and lesser occipital nerve at the superficial cervical plexus level. The block would cover both the sensory innervation and of the ear canal and the inner ear. A regional anesthetic block prior to the surgical intervention on the inner ear at the superficial cervical plexus block is performed. This latter is a branch of the vagus nerve at the superficial cervical plexus (erb's point). The block would inhibit the vagal afferent to area postrema through inhibition of afferent vagal input to the medullary center.
The emetic act (vomiting) is a highly integrated physiologic reflex involving both the somatic and autonomic nervous system. Researchers do not know how much of a relation there is between the vagal nerve branches involvement and incidence of nausea and vomiting effects are from the inner ear injury and or the inflammatory response type of response triggering the area postrema. The usual prophylactic treatment of PONV (post operative nausea and vomiting) has been limited to anti-emetics such as dexamethasone along with aggressive fluid therapy and adequate analgesia.
Investigators are proposing to conduct a comparative study of the therapeutic and cost effectiveness of regional anesthesia and antiemetic therapy in the prevention and treatment of PONV in children undergoing inner ear surgical procedures.
- Conditions
- Anesthesia, Pediatrics, Surgery
- Being tested
- regional nerve block, Antiemetic
- Keywords
- post operative nausea vomiting, Inner ear surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional nerve blockProcedure or surgery
Also called Bupivacaine
regional nerve block
AntiemeticDrug
Also called Dexamethasone (Decadron), ondansetron (Zofran)
Antiemetic
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A - regional nerve block Receives: Procedure: regional nerve block |
| Group B | Active comparator | Group B - antiemetic Receives: Drug: Antiemetic |
| Group C | Active comparator | Group C - block and antiemetic Receives: Procedure: regional nerve block; Drug: Antiemetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Post Operative Nausea and Vomiting
number of patients with evidence of post operative nausea and vomiting
Measured: Post Operative within 24 hour Follow up Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: PI has left Riley Anesthesia. Lack of staff for continued recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia, Pediatrics, SurgeryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles W. Yates, Indiana University
- Investigators
- Malik Nouri, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724033
- Sponsor's protocol ID
- Inner Ear PONV_Nouri
- Status last verified
- May 2020
- First submitted
- 21 Apr 2015
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block With Intravenous Antiemetic Drugs Dexamethasone and Ondansetron and Incidence of Post-operative Nausea Vomiting for Inner Ear Surgery
- ClinicalTrials.gov ID
- NCT02724033
- Acronym / sponsor ID
- Inner Ear PONV_Nouri
- Conditions
- Anesthesia, Pediatrics, Surgery
- Keywords
- post operative nausea vomiting, Inner ear surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left Riley Anesthesia. Lack of staff for continued recruitment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored.
The rational is based on the knowledge of the anatomical innervation of the inner ear and the role of the parasympathetic nervous system in the emetic act. A lot of focus has been given on its counterpart the sympathetic nervous system and its role in painful conditions. The investigators believe that the nerve blockade of the parasympathetic innervation can have some beneficial effect in the post-surgical patient.
Detailed description
The researchers hypothesize another potential antiemetic mechanism by the blockade of the auricular branch of the vagus nerve at the ear canal (commonly described as nerve of Arnold) in conjunction with a block of the greater auricular nerve and lesser occipital nerve at the superficial cervical plexus level. The block would cover both the sensory innervation and of the ear canal and the inner ear. A regional anesthetic block prior to the surgical intervention on the inner ear at the superficial cervical plexus block is performed. This latter is a branch of the vagus nerve at the superficial cervical plexus (erb's point). The block would inhibit the vagal afferent to area postrema through inhibition of afferent vagal input to the medullary center.
The emetic act (vomiting) is a highly integrated physiologic reflex involving both the somatic and autonomic nervous system. Researchers do not know how much of a relation there is between the vagal nerve branches involvement and incidence of nausea and vomiting effects are from the inner ear injury and or the inflammatory response type of response triggering the area postrema. The usual prophylactic treatment of PONV (post operative nausea and vomiting) has been limited to anti-emetics such as dexamethasone along with aggressive fluid therapy and adequate analgesia.
Investigators are proposing to conduct a comparative study of the therapeutic and cost effectiveness of regional anesthesia and antiemetic therapy in the prevention and treatment of PONV in children undergoing inner ear surgical procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: regional nerve blockGroup A - regional nerve block |
| Group B | Active comparator | Drug: AntiemeticGroup B - antiemetic |
| Group C | Active comparator | Procedure: regional nerve block, Drug: AntiemeticGroup C - block and antiemetic |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient Age 1-18 yo
- Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
- Past history of PONV susceptibility
Key exclusion criteria (6 listed)
- Patient/ Parents refusal
- Infection at the site of local anesthetic injection
- Known coagulopathy
- Existing VP shunt
- Severe mental disability
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 |
|---|---|---|
| regional nerve blockAlso: Bupivacaineregional nerve block | Procedure or surgery | Group A, Group C |
| AntiemeticAlso: Dexamethasone (Decadron), ondansetron (Zofran)Antiemetic | Drug | Group B, Group C |
Primary outcome
Evidence of Post Operative Nausea and Vomiting
Time frame: Post Operative within 24 hour Follow up Period
number of patients with evidence of post operative nausea and vomiting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anesthesia, Pediatrics, Surgery
RecruitingPhase 2
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Anesthesia, Pediatric Surgery
Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
Postoperative Pain, Caudal Anesthesia
RecruitingObservational study
Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery
Acute Kidney Injury
Recruiting
Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery
Tracheal Intubation, Videolaryngoscopy
Not yet recruiting
Bookbased Emotion and Anxiety Reduction
Pediatric Anesthesia, Pediatric Surgery
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.
Malik Nouri, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing regional nerve block and Antiemetic in people with Anesthesia, Pediatrics, Surgery, run by Indiana University 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: stopped early, as of the sponsor's last update on 16 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence of Post Operative Nausea and Vomiting (time frame: Post Operative within 24 hour Follow up Period). 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 16 Jun 2020.