Clinical trial NCT02724033: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia, Pediatrics, Surgery
Keywords: post operative nausea vomiting
Inner ear surgery
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Evidence of Post Operative Nausea and Vomiting
timeFrame: Post Operative within 24 hour Follow up Period
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Malik Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References: