Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures

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.

Conditions

• Pain

Interventions

DRUG

Acetaminophen

receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Antonios Likourezos

  lead OTHER

Principal Investigators

• Judy Lin, MD · Maimonides Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2024-03-04

Completion

2024-03-04

FDA Drug

Yes

Countries

• United States

Study Locations