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

NCT04530149 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-03-17
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain; Pain management; Rib

Outcome Measures

Primary Outcomes (1)

• Pain Control

  Pain score on 11 point Numeric Rating Scale ranging 0-10 with 0 being no pain, 5 being moderate pain, and 10 being very severe pain

  60 minutes

Study Arms (2)

serratus anterior plane block group

ACTIVE COMPARATOR

The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.

Drug: Acetaminophen; Drug: Bupivacain

Placebo injection group

PLACEBO COMPARATOR

The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.

Drug: Acetaminophen; Drug: Saline

Interventions

Acetaminophen DRUG

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

Placebo injection group; serratus anterior plane block group

Bupivacain DRUG

The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.

serratus anterior plane block group

Saline DRUG

The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.

Placebo injection group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Presumed/Clinically apparent 2 or more acute unilateral rib fractures between T3-T9
• Pain Score 5 or greater

You may not qualify if:

• GCS\<13
• Penetrating trauma
• Pregnant
• Unable to give consent due to dementia or altered mental status
• Unable to perform spirometry
• Requiring immediate surgical intervention
• Known allergy to amide-type local anesthetics
• Signs of infection or laceration at injection site
• Systolic BP \<100 mmHg
• History of chronic pain, chronic use of analgesics
• History of substance abuse
• Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of rib fracture pain, i.e. femur fracture, dislocated joint)
• If patient received any other pain medication besides ketamine prior to the block
• Only posterior rib fractures present
• known allergy to acetaminophen

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Acetaminophen; Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Research Administration Director
• Organization: Maimonides Medical Center

alikourezos@maimo.org

7182836896

Study Officials

• Judy Lin, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: November 1, 2021
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)