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

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168710
• Other study ID #: 2000025328
• Secondary ID: No NIH funding
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Cristiana Baloescu, MD
• Phone: 203 785 2353
• Email: Cristiana.Baloescu[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Fractures, Bone
• Rib Fractures

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital length of stay (LOS)	LOS will be identified through the electronic medical record.	From hospital admission to hospital discharge, up to 30 days.
Secondary	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.
Secondary	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.
Secondary	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.