Trial Outcomes & Findings for Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery (NCT NCT02724033)
NCT ID: NCT02724033
Last Updated: 2020-06-16
Results Overview
number of patients with evidence of post operative nausea and vomiting
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Post Operative within 24 hour Follow up Period
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
Group A
Group A - regional nerve block
regional nerve block: regional nerve block
|
Group B
Group B - antiemetic
Antiemetic: Antiemetic
|
Group C
Group C - block and antiemetic
regional nerve block: regional nerve block
Antiemetic: Antiemetic
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
12
|
|
Overall Study
COMPLETED
|
11
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=11 Participants
Group A - regional nerve block
regional nerve block: regional nerve block
|
Group B
n=14 Participants
Group B - antiemetic
Antiemetic: Antiemetic
|
Group C
n=12 Participants
Group C - block and antiemetic
regional nerve block: regional nerve block
Antiemetic: Antiemetic
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=11 Participants
|
14 Participants
n=14 Participants
|
12 Participants
n=12 Participants
|
37 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
5 Participants
n=14 Participants
|
8 Participants
n=12 Participants
|
16 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
9 Participants
n=14 Participants
|
4 Participants
n=12 Participants
|
21 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
14 participants
n=14 Participants
|
12 participants
n=12 Participants
|
37 participants
n=37 Participants
|
|
Nausea
|
0 Participants
n=11 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=37 Participants
|
|
Retching
|
0 Participants
n=11 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=37 Participants
|
|
Nausea and Retching
|
0 Participants
n=11 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Post Operative within 24 hour Follow up PeriodPopulation: Patients that had inner ear surgery and the above randomized intervention
number of patients with evidence of post operative nausea and vomiting
Outcome measures
| Measure |
Group A
n=11 Participants
Group A - regional nerve block
regional nerve block: regional nerve block
|
Group B
n=14 Participants
Group B - antiemetic
Antiemetic: Antiemetic
|
Group C
n=12 Participants
Group C - block and antiemetic
regional nerve block: regional nerve block
Antiemetic: Antiemetic
|
|---|---|---|---|
|
Evidence of Post Operative Nausea and Vomiting
Nausea
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Evidence of Post Operative Nausea and Vomiting
No Nausea
|
5 Participants
|
8 Participants
|
8 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=11 participants at risk
Group A - regional nerve block
regional nerve block: regional nerve block
|
Group B
n=14 participants at risk
Group B - antiemetic
Antiemetic: Antiemetic
|
Group C
n=12 participants at risk
Group C - block and antiemetic
regional nerve block: regional nerve block
Antiemetic: Antiemetic
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hives
|
9.1%
1/11 • Number of events 1 • 1 day
|
0.00%
0/14 • 1 day
|
0.00%
0/12 • 1 day
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/11 • 1 day
|
7.1%
1/14 • Number of events 1 • 1 day
|
0.00%
0/12 • 1 day
|
Additional Information
Dr. Charles Yates, Primary Investigator
Department of Otolaryngology, Indiana University School of Medicine
Phone: 317-278-1286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place