Trial Outcomes & Findings for Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures (NCT NCT04530149)
NCT ID: NCT04530149
Last Updated: 2024-06-11
Results Overview
Pain score on 11 point Numeric Rating Scale ranging 0-10 with 0 being no pain, 5 being moderate pain, and 10 being very severe pain
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
60 minutes
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Serratus Anterior Plane Block Group
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Bupivacain: The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
Placeoo Injection Group
The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Saline: The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
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 |
Serratus Anterior Plane Block Group
n=1 Participants
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Bupivacain: The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
Placeoo Injection Group
n=2 Participants
The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Saline: The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPain score on 11 point Numeric Rating Scale ranging 0-10 with 0 being no pain, 5 being moderate pain, and 10 being very severe pain
Outcome measures
| Measure |
Serratus Anterior Plane Block Group
n=1 Participants
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Bupivacain: The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
Placeoo Injection Group
n=2 Participants
The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.
Acetaminophen: receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Saline: The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
|
|---|---|---|
|
Pain Control
|
5 score on a scale
Interval 5.0 to 5.0
|
2.5 score on a scale
Interval 0.0 to 5.0
|
Adverse Events
Serratus Anterior Plane Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placeoo Injection Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Administration Director
Maimonides Medical Center
Phone: 7182836896
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place