Back to resultsUltrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
Primary Purpose
Rib Fractures
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ESP block with bupivacaine
Saline control/sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures
Eligibility Criteria
Inclusion Criteria:
- radiographic evidence of unilateral rib fracture(s).
- able to consent and actively participate in the study.
- moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.
Exclusion Criteria:
- known allergy or hypersensitivity to local anesthetics or morphine.
- infection at site of ESP block placement.
- depth over 5 cm from skin to transverse process visualized with ultrasound.
- additional injuries that preclude positioning for ESP block placement.
- severe traumatic brain or spinal cord injury.
- severe altered mental status, such that pain could not be assessed.
- extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
- adjunctive epidural catheter pain control.
- other regional anesthetic blocks.
- pregnancy or prisoner status.
- unstable vital signs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
erector spinae plane block (ESP block) with bupivacaine
ESP block with saline/sham injection
Arm Description
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
Outcomes
Primary Outcome Measures
Total intravenous (IV) and oral narcotic analgesic use
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
Secondary Outcome Measures
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Hospital length of stay (LOS)
LOS will be identified through the electronic medical record.
Number of Patients Who Develop Pneumonia
Identified through review of the electronic medical record for a discharge diagnosis of pneumonia, or readmission diagnosis of pneumonia within 1 month from presentation.
Adverse events associated with the nerve block itself.
Adverse events will include: hypotension, respiratory depression, and nausea or vomiting. Hypotension will be defined as a systolic blood pressure < 90 mmHg and respiratory depression as respiratory rate < 10 breaths per minute. Nausea or vomiting will be defined as patient-reported sensation of nausea or actual emesis, documented emesis in the medical record, or administration of an antiemetic during the study period.
Total non-narcotic analgesic use.
Non-narcotic analgesic use will be measured by medical record review of all non-narcotic medications. Groups will be compared with respect to each category: non-steroidal anti-inflammatory use, acetaminophen use, local anesthetic patch use.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04168710
Brief Title
Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
Official Title
Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
Detailed Description
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.
Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.
Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The clinical team taking care of the patient as well as the patient will be blinded as to allocation to experimental or control group. The physician administering the block will also be blinded to the substance administered.
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
erector spinae plane block (ESP block) with bupivacaine
Arm Type
Experimental
Arm Description
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
Arm Title
ESP block with saline/sham injection
Arm Type
Placebo Comparator
Arm Description
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
Intervention Type
Drug
Intervention Name(s)
ESP block with bupivacaine
Intervention Description
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
Intervention Type
Other
Intervention Name(s)
Saline control/sham injection
Intervention Description
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
Primary Outcome Measure Information:
Title
Total intravenous (IV) and oral narcotic analgesic use
Description
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
Time Frame
From enrollment/baseline in the study through the study period, up to 24 hours.
Secondary Outcome Measure Information:
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
Baseline (immediately following recruitment).
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
30 minutes post-baseline
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
1 hour post-baseline
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
4 hours post-baseline
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
12 hours post-baseline
Title
Pain score
Description
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time Frame
24 hours post-baseline
Title
Hospital length of stay (LOS)
Description
LOS will be identified through the electronic medical record.
Time Frame
From hospital admission to hospital discharge, up to 30 days.
Title
Number of Patients Who Develop Pneumonia
Description
Identified through review of the electronic medical record for a discharge diagnosis of pneumonia, or readmission diagnosis of pneumonia within 1 month from presentation.
Time Frame
From admission to 30 days from admission.
Title
Adverse events associated with the nerve block itself.
Description
Adverse events will include: hypotension, respiratory depression, and nausea or vomiting. Hypotension will be defined as a systolic blood pressure < 90 mmHg and respiratory depression as respiratory rate < 10 breaths per minute. Nausea or vomiting will be defined as patient-reported sensation of nausea or actual emesis, documented emesis in the medical record, or administration of an antiemetic during the study period.
Time Frame
Within two hours of administration of the nerve block.
Title
Total non-narcotic analgesic use.
Description
Non-narcotic analgesic use will be measured by medical record review of all non-narcotic medications. Groups will be compared with respect to each category: non-steroidal anti-inflammatory use, acetaminophen use, local anesthetic patch use.
Time Frame
From enrollment/baseline in the study through the study period, up to 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
radiographic evidence of unilateral rib fracture(s).
able to consent and actively participate in the study.
moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.
Exclusion Criteria:
known allergy or hypersensitivity to local anesthetics or morphine.
infection at site of ESP block placement.
depth over 5 cm from skin to transverse process visualized with ultrasound.
additional injuries that preclude positioning for ESP block placement.
severe traumatic brain or spinal cord injury.
severe altered mental status, such that pain could not be assessed.
extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
adjunctive epidural catheter pain control.
other regional anesthetic blocks.
pregnancy or prisoner status.
unstable vital signs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiana Baloescu, MD
Phone
203 785 2353
Email
Cristiana.Baloescu@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Shaw
Phone
203 785 7124
Email
melissa.m.shaw@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiana Baloescu, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
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