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Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery

Primary Purpose

Anesthesia, Pediatrics, Surgery

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
regional nerve block
Antiemetic
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, Pediatrics, Surgery focused on measuring post operative nausea vomiting, Inner ear surgery

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient Age 1-18 yo
  • Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
  • Past history of PONV susceptibility

Exclusion Criteria:

  • 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)

Sites / Locations

  • Riley Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Group A - regional nerve block

Group B - antiemetic

Group C - block and antiemetic

Outcomes

Primary Outcome Measures

Evidence of Post Operative Nausea and Vomiting
number of patients with evidence of post operative nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
April 21, 2015
Last Updated
May 27, 2020
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT02724033
Brief Title
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
PI has left Riley Anesthesia. Lack of staff for continued recruitment
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Pediatrics, Surgery
Keywords
post operative nausea vomiting, Inner ear surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A - regional nerve block
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B - antiemetic
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Group C - block and antiemetic
Intervention Type
Procedure
Intervention Name(s)
regional nerve block
Other Intervention Name(s)
Bupivacaine
Intervention Description
regional nerve block
Intervention Type
Drug
Intervention Name(s)
Antiemetic
Other Intervention Name(s)
Dexamethasone (Decadron), ondansetron (Zofran)
Intervention Description
Antiemetic
Primary Outcome Measure Information:
Title
Evidence of Post Operative Nausea and Vomiting
Description
number of patients with evidence of post operative nausea and vomiting
Time Frame
Post Operative within 24 hour Follow up Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient Age 1-18 yo Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery Past history of PONV susceptibility Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Nouri, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery

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