Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures

NCT05069961 | Withdrawn DMC

• 1 other identifier: 11414
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (2)

• MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.

  Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.

  24 hours after catheter placement

• MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.

  Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.

  72 hours after catheter placement

Secondary Outcomes (1)

• Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.

  After patient discharge up to 7 days

Other Outcomes (13)

• Incentive spirometry

  Baseline, pre-intervention and immediately following intervention.

• Rate of adverse events/complications related to ESPB and TEA

  Duration of hospital stay up to 7 days.

• Dermatome levels with analgesia

  Immediately following infusion.

Study Arms (2)

ESPB Group

ACTIVE COMPARATOR

20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.

Procedure: ESPB

TEA Group

ACTIVE COMPARATOR

5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.

Procedure: TEA

Interventions

ESPB PROCEDURE

Ropivacaine is injected near the nerves in the back

ESPB Group

TEA PROCEDURE

Bupivacaine is injected into the space around the spinal cord.

TEA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Radiological evidence of 3 or more rib fractures
• Within 48 hours of admission to hospital with rib fractures
• Can actively participate by answering questions during TEA or ESPB placement
• Moderate-severe (4-10 out of 10) pain at the time of enrollment

You may not qualify if:

• Greater than 48 hrs since admission to the hospital with rib fractures
• Patient refusal
• Prisoner
• Infection at the site of TEA or ESPB insertion
• Allergy to local anesthetics
• Depth from skin to catheter placement target 6 or more centimeters
• Greater than 7 consecutive ribs involved on each side
• Other regional or epidural block already received
• Unable to follow commands/altered mental status
• Dementia
• Sepsis (temperature \> 38 degrees Celsius \& positive blood cultures)
• Elevated intracranial pressure (ICP \> 12 mm Hg)
• Coagulopathy (INR \> 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on)
• Preexisting central nervous system disorders, such as multiple sclerosis
• Thrombocytopenia (Platelets \<70,000)

Sponsors & Collaborators

• Indiana University: lead

Related Publications (42)

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MeSH Terms

Conditions

Rib Fractures

Interventions

Tea

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ross Mirman, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesia

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 6, 2021
• Study Start: May 31, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share