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

NCT02724033 | Terminated Phase 4 Results

• 1 other identifier: Inner Ear PONV_Nouri
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Pediatrics, Surgery

Keywords

post operative nausea vomiting; Inner ear surgery

Outcome Measures

Primary Outcomes (1)

• Evidence of Post Operative Nausea and Vomiting

  number of patients with evidence of post operative nausea and vomiting

  Post Operative within 24 hour Follow up Period

Study Arms (3)

Group A

ACTIVE COMPARATOR

Group A - regional nerve block

Procedure: regional nerve block

Group B

ACTIVE COMPARATOR

Group B - antiemetic

Drug: Antiemetic

Group C

ACTIVE COMPARATOR

Group C - block and antiemetic

Procedure: regional nerve block; Drug: Antiemetic

Interventions

regional nerve block PROCEDURE

regional nerve block

Also known as: Bupivacaine

Group A; Group C

Antiemetic DRUG

Antiemetic

Also known as: Dexamethasone (Decadron), ondansetron (Zofran)

Group B; Group C

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Bupivacaine; Antiemetics; Dexamethasone; Calcium Dobesilate; Ondansetron

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Number of patients is less than expected.

Results Point of Contact

• Title: Dr. Charles Yates, Primary Investigator
• Organization: Department of Otolaryngology, Indiana University School of Medicine

cwyates@iupui.edu

317-278-1286

Study Officials

• Malik Nouri, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: March 31, 2016
• Study Start: May 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-05

Locations

US (1)