The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients

NCT03805360 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HM20014264
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (3)

• Change in numeric pain score rating at rest (before incentive spirometry exercise)

  Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)

  Baseline and at 45 minutes after ESP block

• Change in numeric pain score rating with respiration (after incentive spirometry exercise)

  Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)

  Baseline and at 45 minutes after ESP block

• Change in incentive spirometry values

  Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.

  Baseline and at 45 minutes after ESP block

Study Arms (2)

ESP block with normal saline

SHAM COMPARATOR

An erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane.

Drug: Normal Saline Flush, 0.9% Injectable Solution

ESP block with local anesthetic

EXPERIMENTAL

An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.

Also known as: Local anesthetic

ESP block with local anesthetic

Normal Saline Flush, 0.9% Injectable Solution DRUG

Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.

Also known as: 0.9% Sodium Chloride

ESP block with normal saline

Eligibility Criteria

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

You may qualify if:

• Blunt chest trauma
• Sustaining at least 3 unliateral rib fractures
• Resultant vital capacity less than 30% predicted
• Pain score reaches threshold despite using the current institutional standard of care for pain control

You may not qualify if:

• Patients whose weight less than 60kg.
• Patients with bilateral rib fractures.
• Patients that are intubated and mechanically ventilated.
• Pregnant Individuals.
• Any individual with a documented allergy to ropivacaine.
• Patients with limited English proficiency (LEP)
• Patients whose body habitus prevents the practitioner's ability to adequately perform the procedure.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Rib Fractures

Interventions

Ropivacaine; Anesthetics, Local; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bryant Tran, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: May 24, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

US (1)