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PI has left Riley Anesthesia. Lack of staff for continued recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A - regional nerve block |
|
| Group B | Active Comparator | Group B - antiemetic |
|
| Group C | Active Comparator | Group C - block and antiemetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional nerve block | Procedure | regional nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malik Nouri, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Group A - regional nerve block regional nerve block: regional nerve block |
| FG001 | Group B | Group B - antiemetic Antiemetic: Antiemetic |
| FG002 | Group C | Group C - block and antiemetic regional nerve block: regional nerve block Antiemetic: Antiemetic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Group A - regional nerve block regional nerve block: regional nerve block |
| BG001 | Group B | Group B - antiemetic Antiemetic: Antiemetic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Post Operative Nausea and Vomiting | number of patients with evidence of post operative nausea and vomiting | Patients that had inner ear surgery and the above randomized intervention | Posted | Count of Participants | Participants | Post Operative within 24 hour Follow up Period |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Group A - regional nerve block regional nerve block: regional nerve block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hives | Skin and subcutaneous tissue disorders | vomiting | Non-systematic Assessment |
Number of patients is less than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Yates, Primary Investigator | Department of Otolaryngology, Indiana University School of Medicine | 317-278-1286 | cwyates@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2017 | May 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000932 | Antiemetics |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Antiemetic | Drug | Antiemetic |
|
|
| BG002 | Group C | Group C - block and antiemetic regional nerve block: regional nerve block Antiemetic: Antiemetic |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nausea | Count of Participants | Participants |
|
| Retching | Count of Participants | Participants |
|
| Nausea and Retching | Count of Participants | Participants |
|
Group C - block and antiemetic regional nerve block: regional nerve block Antiemetic: Antiemetic |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Group B | Group B - antiemetic Antiemetic: Antiemetic | 0 | 14 | 0 | 14 | 1 | 14 |
| EG002 | Group C | Group C - block and antiemetic regional nerve block: regional nerve block Antiemetic: Antiemetic | 0 | 12 | 0 | 12 | 0 | 12 |
| Hematoma | Skin and subcutaneous tissue disorders | vomiting | Non-systematic Assessment |
|
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| D000588 |
| Amines |
| D001337 | Autonomic Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D005765 | Gastrointestinal Agents |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|