Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
NCT ID: NCT05069961
Last Updated: 2023-10-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-31
Study Completion Date
2025-07-31
Brief Summary
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The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
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Detailed Description
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2.1 Primary Objective
* Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
* Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
* Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
* Compare complications that occur in patients who receive ESPB versus TEA.
* Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
* Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
* Differences in length of stay (LOS) for TEA versus ESPB.
* Differences in risk of delirium between TEA and ESPB.
* Differences in oxygen and ventilatory support between TEA and ESPB.
* Patient satisfaction of pain management.
* Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
* Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
* Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
* Compare complications that occur in patients who receive ESPB versus TEA.
* Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
* Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
* Differences in length of stay (LOS) for TEA versus ESPB.
* Differences in risk of delirium between TEA and ESPB.
* Differences in oxygen and ventilatory support between TEA and ESPB.
* Patient satisfaction of pain management.
Conditions
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Rib Fractures
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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ESPB Group
20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.
Group Type
ACTIVE_COMPARATOR
ESPB
Intervention Type
PROCEDURE
Ropivacaine is injected near the nerves in the back
TEA Group
5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.
Group Type
ACTIVE_COMPARATOR
TEA
Intervention Type
PROCEDURE
Bupivacaine is injected into the space around the spinal cord.
Interventions
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ESPB
Ropivacaine is injected near the nerves in the back
Intervention Type
PROCEDURE
TEA
Bupivacaine is injected into the space around the spinal cord.
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 18 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
* 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
Exclusion Criteria
* 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)
* Spine fracture or previous back surgery
* Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
* Aortic transection
* Hemodynamic instability (patients with MAPs \<60 and/or patients requiring pressor support)
* Tattoo at sight of catheter placement
* 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)
* Spine fracture or previous back surgery
* Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
* Aortic transection
* Hemodynamic instability (patients with MAPs \<60 and/or patients requiring pressor support)
* Tattoo at sight of catheter placement
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Ross Mirman
Assistant Professor of Clinical Anesthesia
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ross Mirman, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
References
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Yayik AM, Ahiskalioglu A, Celik EC, Ay A, Ozenoglu A. [Continuous erector spinae plane block for postoperative analgesia of multiple rib fracture surgery: case report]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):91-94. doi: 10.1016/j.bjan.2018.08.001. Epub 2018 Nov 2.
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Cao J, Gao X, Zhang X, Li J, Zhang J. Feasibility of laryngeal mask anesthesia combined with nerve block in adult patients undergoing internal fixation of rib fractures: a prospective observational study. BMC Anesthesiol. 2020 Jul 15;20(1):170. doi: 10.1186/s12871-020-01082-y.
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Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.
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Gursoy C, Kuscu Y, Demirbilek SG. Pain Management for Traumatic Rib Fractures with ESP Block in ICU. J Coll Physicians Surg Pak. 2020 Mar;30(3):318-320. doi: 10.29271/jcpsp.2020.03.318.
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Liu R, Clark L, Bautista A. Unilateral Bilevel Erector Spinae Plane Catheters for Flail Chest: A Case Report. A A Pract. 2020 May;14(7):e01211. doi: 10.1213/XAA.0000000000001211.
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Epidural Anesthesia and Analgesia [https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/abdomen/epidural-anesthesia-analgesia/]
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BACKGROUND
Bomberg H, Bayer I, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Prolonged Catheter Use and Infection in Regional Anesthesia: A Retrospective Registry Analysis. Anesthesiology. 2018 Apr;128(4):764-773. doi: 10.1097/ALN.0000000000002105.
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Other Identifiers
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11414
Identifier Type: -
Identifier Source: org_study_id
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