Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rib Fractures
• Intervention / Treatment: Drug: ESP block with bupivacaine; Other: Saline control/sham injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Cristiana Baloescu, MD; Phone Number: 203 785 2353; Email: Cristiana.Baloescu@yale.edu
• Study Contact Backup: Name: Melissa Shaw; Phone Number: 203 785 7124; Email: melissa.m.shaw@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. radiographic evidence of unilateral rib fracture(s).
2. able to consent and actively participate in the study.
3. moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.

Exclusion Criteria:

1. known allergy or hypersensitivity to local anesthetics or morphine.
2. infection at site of ESP block placement.
3. depth over 5 cm from skin to transverse process visualized with ultrasound.
4. additional injuries that preclude positioning for ESP block placement.
5. severe traumatic brain or spinal cord injury.
6. severe altered mental status, such that pain could not be assessed.
7. extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
8. adjunctive epidural catheter pain control.
9. other regional anesthetic blocks.
10. pregnancy or prisoner status.
11. unstable vital signs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erector spinae plane block (ESP block) with bupivacaine; 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.	Drug: ESP block with bupivacaine; 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.
Placebo Comparator: ESP block with saline/sham injection; 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.	Other: Saline control/sham injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intravenous (IV) and oral narcotic analgesic use	narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.	From enrollment/baseline in the study through the study period, up to 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline (immediately following recruitment).
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)	30 minutes post-baseline
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)	1 hour post-baseline
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)	4 hours post-baseline
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)	12 hours post-baseline
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)	24 hours post-baseline
Hospital length of stay (LOS)	LOS will be identified through the electronic medical record.	From hospital admission to hospital discharge, up to 30 days.
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.	From admission to 30 days from admission.
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.	Within two hours of administration of the nerve block.
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.	From enrollment/baseline in the study through the study period, up to 24 hours.

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Cristiana Baloescu, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Thoracic Injuries; Emergencies; Fractures, Bone; Rib Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2000025328; No NIH funding (Other Identifier: 01.22.24)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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