Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04530149 |
| Other study ID # |
2019-03-17 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
March 4, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
I. Background:
Patients with multiple rib fractures are challenging from both pulmonary and analgesia
perspectives. Adequate pain management is essential in prevention of complications secondary
to decreased inspiratory volume. Significant morbidity and mortality of rib fractures is
secondary to severe pain that limits ribcage movement, decreases inspiratory volumes and
causes inadequate cough. Decreased vital capacity predisposes patients to atelectasis,
abnormal mucous clearance and pneumonia. The objective of this study is to assess the
efficacy of the serratus anterior plane block (SAPB) in improvement of vital capacity in
patients with multiple unilateral rib fractures when compared to conventional management with
medications. Currently, evidence of efficacy of SAPB in managing pain secondary to multiple
rib fractures is limited to case reports and series, none of which evaluate vital capacity.
II. Significance:
The findings of this study may indicate that SAPB is superior to pharmacological management
in increasing vital capacity in patients with multiple unilateral rib fractures and suggest
SAPB for first line therapy in patients with rib fractures. The findings may decrease the
risk of pulmonary complications as well as the use of opiates in management of multiple rib
fractures in the Emergency Department especially in patients with numerous comorbidities and
contraindications to conventional treatment modalities. This study may support the need for
training emergency medicine physicians in bedside SAPB in order to provide the optimal
therapy for patient with multiple unilateral rib fractures.
III. Study Objectives:
The primary objectives are to evaluate whether ultrasound guided SAPB results in a greater
improvement in percent predicted vital capacity compared to standard therapy with a sham
injection. The investigators will also evaluate pain scores and the safety profile of the
SAPB procedure compared to those receiving standard analgesia.
IV. Hypothesis:
The primary hypothesis is that SAPB is superior to sham injection in improving the percent of
predicted vital capacity. The secondary hypothesis is that SAPB will have greater improvement
in pain scores and have a superior safety profile compared to placebo injection.
Description:
STUDY DESIGN
This is a single center prospective, randomized, blinded clinical trial with a convenience
sample that will be conducted in the Emergency Department of an urban level I trauma center.
A. Identify and enroll all patients coming in to the ED patient with presumed or clinically
apparent 2 or more unilateral rib fractures between T3 to T9, with a resting pain score of
≥5. All patients meeting exclusion criteria will be excluded.
B. Randomization procedure:
1. Pharmacy will dispense 30mL of injectate which will be randomized in block of 10 to
either the SAPB group (30mL of 0.25% bupivacaine with epinephrine) or sham group (30mL
of normal saline).
C. Injection
1. Patient consent will be obtained and time out will be performed on all patients.
2. Patients will be placed on cardiac monitor and placed in lateral decubitus or if unable
to turn, they will be supine.
3. Under the usual sterile technique, the serratus anterior muscle overlying the 5th rib at
the mid-axillary line will be identified with ultrasound.
4. A spinal needle will be introduced in-plane under ultrasound guidance and advanced until
the needle tip is located in the fascial plane just above the serratus anterior muscle.
The needle tip will not be advanced unless completely visualized under ultrasound.
5. Normal saline will be injected first to determine correct location of the needle tip.
Spreading of fluid along the fascial plane will confirm the correct location of the
needle tip.
6. The normal saline will then be switched to the study drug of which 30mL of either normal
saline or 0.25% bupivacaine with epinephrine which will then be injected into the
fascial plane as described in Blanco et al, and Hetta et al.
7. The study drug will be injected 5mL at a time and the patient will be asked if any
symptoms of Local Anesthetic Systemic Toxicity (LAST toxicity) are present (perioral
numbness, tinnitus, dizziness).
8. After injection is completed the needle will be withdrawn and patient will remain on the
cardiac monitor for another 30 minutes to monitor for symptoms of LAST toxicity (Di
Gregorio).
9. This procedure was based on the serratus anterior plane block protocol from Khalil et
al.
D. Slow Vital Capacity (SVC) Measurement
1. SVC will be performed using spirometer that has been internally validated
2. SVC will be performed by physicians trained by the respiratory therapy department and
who have demonstrated validation compared to respiratory therapist obtained SVC values
3. The patient will be sitting up when performing SVC and a script will be followed as to
how to educate and coach the patient on performing appropriate incentive spirometry
technique.
4. At least 3 SVC measurements within 150mL of each other are required to qualify for an
accurate measurement.
5. The maximum of these 3 SVC values and a corresponding % predicted SVC will be obtained
and considered the maximum % predicted SVC.
6. % Predicted SVC will be obtained based on the National Health and Nutrition Examination
Survey (NHANES III) calculator through the CDC.
E. Pain scores
1. Subjects will be asked to rate their maximum pain score from 0-10 with resting breathing
and with deep breaths.
Design:
A. Potential study patients will be identified through review of the emergency department
(ED) electronic board, and ED physicians will also screen for potential study patients. Pain
scores are assessed in triage as is standard in the ED.
B. If the patient has pain from presumed or clinically apparent 2 or more unilateral rib
fractures between T3 to T9, and he/she has a resting pain score of ≥5 on the Numeric Pain
Rating Scale, where 0 is no pain, 5 is moderate pain, and 10 is the worst possible pain upon
initial assessment, then he/she will be eligible to participate in the study.
The patient will then be asked to participate if he/she does not have any exclusion criteria.
C. At time of enrollment, the patient will have recorded pain scores, vital signs, and slow
vital capacity measured.
D. All patients will then receive as their initial analgesic oral acetaminophen 975 mg
followed by morphine sulfate 0.05 mg/kg IV rounded to the nearest milligram.
E. Each patient will then be randomized in either of two arms:
1. Ultrasound guided serratus anterior plane block (SAPB) with 30mL 0.25% bupivacaine with
epinephrine.
2. Ultrasound guided serratus anterior plane injection with placebo injection with 30mL of
normal saline.
6. Investigators will be blinded to the arm that the patient has been randomized to, as the
randomization will occur through the pharmacy dispensing the medication.
7. Using an online randomizer in blocks of 10, the pharmacy will dispense either 30mL of
normal saline for the sham group, or 30mL of 0.25% bupivacaine with epinephrine for the nerve
block group.
8. All patients will receive either SAPB or placebo injection within an hour of receiving the
initial analgesics of acetaminophen and morphine.
9. If the patient still has a pain score ≥5 thirty minutes after the injection, the treating
physician will be informed and the patient will be medicated at the treating physician's
discretion.
10. The patient will be followed up with up to 24 hours throughout their hospital stay.
Data Collection Procedures:
A. Demographics 1. Age, sex, ethnicity, height B. Past medical history 1. Smoking status
(current, prior, never smoker), diabetes, cirrhosis, chronic obstructive pulmonary disease
(COPD), asthma, if patient uses home oxygen C. Injury Mechanism
1. Occupant in motor vehicle collision, fall from an elevation, fall down stairs, fall from
standing, pedestrian or bicyclist struck by moving vehicle, bike collision or fall from
bike while riding, driver or passenger in motorcycle/ATV/motorized scooter collision,
assault, unknown mechanism, or other
2. Date and time of injury
3. GCS score
4. Injury Severity Scale D. Imaging
1. Side of rib fractures
2. Number of rib fractures on x-ray and on CT chest
3. Rib fracture location: anterior, lateral, posterior, T1-12
4. Type of imaging showing rib fractures
5. Presence of following: atelectasis, hemothorax, infiltrate (right/left), interstitial
edema, pneumothorax, pulmonary contusion E. Medication
1. Any medications type and dose given prior to randomization
F. At Time 0 (time of enrollment):
1. Vital signs
2. Resting pain score from 0-10
3. Deep breath pain score from 0-10
4. Slow Vital Capacity (SVC)
a. Measured until 3 measurements are within 150mL of each other b. % predicted SVC is
measured based on NHANES III Calculator using age, sex, ethnicity and height. If
ethnicity not included in calculator will select Caucasian.
c. Maximum SVC and maximum % predicted SVC
5. Symptoms after injection: sedation, dizziness, dysarthria, nausea, new cardiac rhythm
(significant tachycardia or bradycardia, SVT, etc), new significantly increased
shortness of breath, perioral numbness, pruritis, seizure, syncope, tinnitus, vomiting
G. At Time 30 minutes post injection
1. Vital signs
2. Resting pain score from 0-10
3. Deep breath pain score from 0-10
4. Slow Vital Capacity (SVC)
1. Measured until 3 measurements are within 150mL of each other
2. Percentage predicted SVC is measured based on NHANES III Calculator using age, sex,
ethnicity and height. If ethnicity not included in calculator will select
Caucasian.
3. Maximum SVC and maximum % predicted SVC
5. Symptoms after injection: sedation, dizziness, dysarthria, nausea, new cardiac rhythm
(significant tachycardia or bradycardia, SVT, etc), new significantly increased
shortness of breath, perioral numbness, pruritis, seizure, syncope, tinnitus, vomiting
H. At Time 60 minutes post injection
1. Vital signs
2. Resting pain score from 0-10
3. Deep breath pain score from 0-10
4. Slow Vital Capacity (SVC)
1. Measured until 3 measurements are within 150mL of each other
2. % predicted SVC is measured based on NHANES III Calculator using age, sex, ethnicity and
height. If ethnicity not included in calculator will select Caucasian.
3. Maximum SVC and maximum % predicted SVC
5. Symptoms after injection: sedation, dizziness, dysarthria, nausea, new cardiac rhythm
(significant tachycardia or bradycardia, SVT, etc), new significantly increased shortness of
breath, perioral numbness, pruritis, seizure, syncope, tinnitus, vomiting I. At Time 3-6
hours post injection
1. Vital signs 2. Resting pain score from 0-10 3. Deep breath pain score from 0-10 4. Slow
Vital Capacity (SVC)
1. Measured until 3 measurements are within 150mL of each other
2. % predicted SVC is measured based on NHANES III Calculator using age, sex, ethnicity and
height. If ethnicity not included in calculator will select Caucasian.
3. Maximum SVC and maximum % predicted SVC 4. Symptoms after injection: sedation,
dizziness, dysarthria, nausea, new cardiac rhythm (significant tachycardia or
bradycardia, SVT, etc), new significantly increased shortness of breath, perioral
numbness, pruritis, seizure, syncope, tinnitus, vomiting J. At Time 12 hours post
injection 1. Vital signs 2. Resting pain score from 0-10 3. Deep breath pain score from
0-10 5. Slow Vital Capacity (SVC)
1. Measured until 3 measurements are within 150mL of each other
2. % predicted SVC is measured based on NHANES III Calculator using age, sex,
ethnicity and height. If ethnicity not included in calculator will select
Caucasian.
3. Maximum SVC and maximum % predicted SVC
5. Symptoms after injection: sedation, dizziness, dysarthria, nausea, new cardiac rhythm
(significant tachycardia or bradycardia, SVT, etc), new significantly increased
shortness of breath, perioral numbness, pruritis, seizure, syncope, tinnitus, vomiting
J. On 24 hours post injection
1. Vital signs
2. Resting pain score from 0-10
3. Deep breath pain score from 0-10
4. Slow Vital Capacity (SVC)
1. Measured until 3 measurements are within 150mL of each other
2. % predicted SVC is measured based on NHANES III Calculator using age, sex, ethnicity and
height. If ethnicity not included in calculator will select Caucasian.
3. Maximum SVC and maximum % predicted SVC 5. Symptoms after injection: sedation,
dizziness, dysarthria, nausea, new cardiac rhythm (significant tachycardia or
bradycardia, SVT, etc), new significantly increased shortness of breath, perioral
numbness, pruritis, seizure, syncope, tinnitus, vomiting K. Slow vital capacity
1. Researchers will be trained on appropriate incentive spirometry technique by the
respiratory therapy team and their accuracy will be confirmed 2. Patients will then be
instructed to perform SVC, we will get 3 SVC measurements within 150mL of each other and
then record the maximum SVC.
3. Percent predicted vital capacity will be calculating using NHANES III L. Time to
first rescue analgesia post injection M. Medications during first 24 hours of hospital
stay
1. 24 hour total morphine milligram equivalent consumption
1. Calculated based on CDC Morphine Milligram Equivalence (MME) Calculator:
https://www.cdc.gov/drugoverdose/prescribing/app.html 2. Any antemetics used after
injection within 24 hours after enrollment 3. Time to administration of first rescue
analgesia post injection N. Nerve Block performed during inpatient stay
1. List date/time/type of any additional nerve blocks performed for rib fracture pain
after the study injection during the patient's hospital stay
O. Pulmonary complications:
1. New O2 requirement, BIPAP or intubation, transfer to ICU for respiratory issue,
development of pneumonia, readmission for pulmonary issue, new need for home O2 P. Nerve
Block Complications
1. Development of cellulitis at site of block during hospital stay 2. Pneumothorax
occurring within 12 hours of injection Q. Discharge Data
1. If cellulitis developed at the site of injection during hospital stay
2. If a pneumothorax on the same side of the injection occurred within 12 hours of
block R. Imaging
1. Videos of the nerve block performance will be recorded in each patient. These images
will later be de-identified and reviewed by two independent reviewers not involved in
the study to determine visually whether the planar spread of anesthetic was correctly
placed or not correctly placed.
