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Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department

Primary Purpose

Rib Fracture Multiple

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector Spinae Plane Block
IV Analgesia
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fracture Multiple

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >=18
  • At least 1 acute rib fracture. Acute defined as within 7 days of presentation.
  • Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure.
  • Admitted to hospital for at least 24 hours of observation.
  • Be able to consent and participate in study by assuming necessary positioning for intervention

Exclusion Criteria:

  • Hypotension/shock (shock index >1.0, SBP < 90)
  • Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.)
  • Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar)
  • Known hypersensitivity to local anesthetic
  • Evidence of infection at the proposed site of injection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ESPB Block

    Standard Care

    Arm Description

    Patients with rib fracture randomized to block group

    Patients with rib fracture receiving IV analgesia/standard care

    Outcomes

    Primary Outcome Measures

    To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale
    Change in pain level from fractures as measured using a visual analog scale

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2021
    Last Updated
    May 15, 2021
    Sponsor
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04892563
    Brief Title
    Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department
    Official Title
    Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    August 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. There have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.
    Detailed Description
    Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. Additionally, even short courses can predispose to life-long addiction perpetuating the opioid epidemic. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently. As an example, ultrasound-guided peripheral nerve blocks for hip fractures have a promising track record for reducing opioid use and improving pain scores. The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. It was first described in 2016 by Forero, et al., as an effective alternative to traditional neuraxial blockade for post-operative and chronic thoracic pain. A recent literature review by Kot et al., 2019 revealed six prospective studies in post-operative patients concluding that the ESPB was at least as effective as opioids in thoracic pain reduction, easy to use and with a low complication rate. One prospective study in post-operative breast surgery patients demonstrated a reduction in morphine by 65% compared to control. Most literature on the ESPB in the ED are case reports, which demonstrate its versatility in a myriad of clinical situations such as renal colic, acute herpes zoster, acute transverse process fractures, extensive burns, mechanical back pain, acute pancreatitis and acute rib fractures. This review found the ESPB to be effective at reducing pain scores for all reported indications with no complications. The ESPB is a particularly attractive multimodal form of analgesia in the ED where acute traumatic rib fractures are a common presentation. Usually the involuntary splinting from acute pain results in the typical pulmonary complications, but high doses of opioids and the subsequent respiratory depressive effects can lead to higher rates of atelectasis, pneumonia and respiratory failure. In order to combat this "between a rock and a hard place" scenario, regional analgesia has emerged as an effective means of improving both pain respiratory mechanics. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. Another consideration of these technically more difficult procedures is that they are relatively contraindicated in the anticoagulated patient precluding a substantial number of elderly patients from their therapeutic benefits. The aforementioned reviews have supported the safety of the ESPB with no complications reported. Specifically, of the 10 case reports utilizing this block in the ED, none reported any complications. The 3 cases reported by Luftig et al, in 2018 specific to ED management of acute rib fractures were technically feasible, highly efficacious and safe. However, there have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, the investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rib Fracture Multiple

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESPB Block
    Arm Type
    Experimental
    Arm Description
    Patients with rib fracture randomized to block group
    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm Description
    Patients with rib fracture receiving IV analgesia/standard care
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector Spinae Plane Block
    Other Intervention Name(s)
    Nerve Block, Erector Spinae Block
    Intervention Description
    Nerve block with local anesthetic in the erector spinae plane
    Intervention Type
    Drug
    Intervention Name(s)
    IV Analgesia
    Other Intervention Name(s)
    Morphine, Opioid
    Intervention Description
    IV analgesia, typically Morphine/Opioid medications
    Primary Outcome Measure Information:
    Title
    To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale
    Description
    Change in pain level from fractures as measured using a visual analog scale
    Time Frame
    0, 1, 2 and 24 hours assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >=18 At least 1 acute rib fracture. Acute defined as within 7 days of presentation. Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure. Admitted to hospital for at least 24 hours of observation. Be able to consent and participate in study by assuming necessary positioning for intervention Exclusion Criteria: Hypotension/shock (shock index >1.0, SBP < 90) Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.) Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar) Known hypersensitivity to local anesthetic Evidence of infection at the proposed site of injection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dana Sajed
    Phone
    858 361 4685
    Email
    sajed@usc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tom Mailhot, MD
    Organizational Affiliation
    LAC+USC Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department

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