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Continuous Erector Spinae Plane Blocks for Rib Fractures

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ClinicalTrials.gov Identifier: NCT04558281
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death.

One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects.

The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures.

The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.


Condition or disease Intervention/treatment Phase
Rib Fractures Trauma Anesthesia Anesthesia, Local Drug: Active ropivacaine 0.3% erector spinae plane perineural administration Drug: Placebo erector spinae plane perineural administration Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study solution containing either local anesthetic (ropivacaine) or saline will be prepared by the UCSD Investigational Drug Study Service. Both ropivacaine and normal saline are clear and indistinguishable visually.
Primary Purpose: Treatment
Official Title: Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
Actual Study Start Date : May 23, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Treatment
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Drug: Active ropivacaine 0.3% erector spinae plane perineural administration
Ropivacaine 0.3% administration via an erector spinae plane perineural catheter

Placebo Comparator: Placebo
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Drug: Placebo erector spinae plane perineural administration
Normal saline administration via an erector spinae plane perineural catheter




Primary Outcome Measures :
  1. Maximal Inspired Volume - Absolute [ Time Frame: Between 1200 and 1700 on the day following the procedure ]
    Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.


Secondary Outcome Measures :
  1. Maximal Inspired Volume - absolute [ Time Frame: Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12 ]
    Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.

  2. Maximal Inspired Volume - Percentage change from baseline prior to intervention [ Time Frame: Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12 ]
    Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.

  3. Brief Pain Inventory (short form, Interference Subscale) [ Time Frame: Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    The Brief Pain Inventory (short form, Interference Subscale) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning [7 questions related specifically to rib fracture pain and not other injuries]

  4. Rib fracture pain when using an incentive spirometer [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain

  5. WORST rib fracture pain in previous 24 hours [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain

  6. AVERAGE rib fracture pain in previous 24 hours [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain

  7. LEAST rib fracture pain in previous 24 hours [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain

  8. CURRENT rib fracture pain in previous 24 hours [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain

  9. Opioid consumption [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Amount of opioid used in last 24 hours (ultimately measured in morphine equivalents)

  10. Sleep disturbances due to rib fracture pain [ Time Frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure ]
    Number of awakenings due to rib fracture pain the previous night



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
  • regional anesthetic requested by the admitting service
  • patient accepting of a perineural catheter insertion and subsequent study fluid treatment.

Exclusion Criteria:

  • chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use > 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care)
  • pregnancy
  • incarceration
  • inability to communicate with the investigators
  • weight < 45 kg or morbid obesity (body mass index > 40 kg/m2)
  • comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural local anesthetic administration (e.g., current infection at the catheter insertion site, known hepatic or renal insufficiency, immune-compromised status of any etiology)
  • any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
  • any patient with any degree of decreased mental capacity as determined by the surgical service
  • any reason an investigator believes study participation would not be in the best interest of the potential subject
  • flail chest
  • chest tube
  • fracture of the 1st rib on either side
  • any injury other than the rib fracture(s) that potentially effects inspiratory effort or volume (e.g., clavicle fracture)
  • inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558281


Contacts
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Contact: John J. Finneran IV, MD 4083073004 jfinneran@ucsd.edu
Contact: Brian M Ilfeld, MD, MS 8584445949 bilfeld@health.ucsd.edu

Locations
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United States, California
University California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Brian Ilfeld, MD, MS    858-822-0776    bilfeld@ucsd.edu   
Contact: John Finneran, MD         
Principal Investigator: Brian M Ilfeld, MD, MS         
Sub-Investigator: John Finneran, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Study Director: John J Finneran IV, MD University of California, San Diego
Principal Investigator: Brian M Ilfeld, MD, MS University of California, San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor in Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04558281    
Other Study ID Numbers: cESPB for Rib Fractures
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents