Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 1 - 18 |
| Updated: | 12/14/2018 |
| Start Date: | May 2014 |
| End Date: | September 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- Patient Age 1-18 yo
- Scheduled to have cochlear implantation, Tampanomastoidectomy, 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)
We found this trial at
1
site
705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Phone: 317-944-9981
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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