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Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

Primary Purpose

Multiple Rib Fractures, Pain, Acute, Serratus Anterior Plane Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided continuous serratus anterior plane block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Rib Fractures focused on measuring serratus anterior plane block, multiple rib fractures

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.

Exclusion Criteria:

  • significant head injury and unconsciousness (GCS less than 14)
  • Patients with significant pain from other injuries
  • pathological obesity (body mass index ≥35)
  • history of drug allergy local anesthetics
  • local infection at the injection site
  • inability to obtain consent from patient or surrogate, and patient refusal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Continuous Deep Serratus Anterior Plane Block group

    Continuous Superficial Serratus Anterior Plane Block group

    Arm Description

    at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

    at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

    Outcomes

    Primary Outcome Measures

    Change in pain score
    patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"

    Secondary Outcome Measures

    Change in inspiratory volumes (mL)
    Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
    The time of the first rescue analgesic and the total analgesic consuption
    when NRS is over 4, 30 mg of i.v ketorlac will be given and its time will be recorded the total dose through 24 hr will be recorded for 3 days
    change in Serum beta-endorphin level
    We will use radioimmunoassays to measure plasma beta-endorphin level
    Lung Ultrasound Score (LUSS)
    We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24).
    hospital stay
    time to fill the discharge criteria
    mean arterial blood pressure
    mean arterial blood pressure by non invaisive blood pressure monitoring
    heart rate
    heart rate by EKG monitor
    peripheral arterial oxygen saturation (SpO2)
    measured by Pulse oximetry

    Full Information

    First Posted
    September 20, 2020
    Last Updated
    December 9, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04575272
    Brief Title
    Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures
    Official Title
    Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 10, 2021 (Anticipated)
    Primary Completion Date
    October 10, 2022 (Anticipated)
    Study Completion Date
    December 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.
    Detailed Description
    Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied. Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia. the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids). The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible. There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Rib Fractures, Pain, Acute, Serratus Anterior Plane Block
    Keywords
    serratus anterior plane block, multiple rib fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous Deep Serratus Anterior Plane Block group
    Arm Type
    Experimental
    Arm Description
    at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.
    Arm Title
    Continuous Superficial Serratus Anterior Plane Block group
    Arm Type
    Active Comparator
    Arm Description
    at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided continuous serratus anterior plane block
    Intervention Description
    Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib
    Primary Outcome Measure Information:
    Title
    Change in pain score
    Description
    patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"
    Time Frame
    before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"
    Secondary Outcome Measure Information:
    Title
    Change in inspiratory volumes (mL)
    Description
    Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
    Time Frame
    before and after block at "90 minutes" then every "12hours" for 3 days
    Title
    The time of the first rescue analgesic and the total analgesic consuption
    Description
    when NRS is over 4, 30 mg of i.v ketorlac will be given and its time will be recorded the total dose through 24 hr will be recorded for 3 days
    Time Frame
    day 0, day 1, day 2, day 3
    Title
    change in Serum beta-endorphin level
    Description
    We will use radioimmunoassays to measure plasma beta-endorphin level
    Time Frame
    before procedure and at 24 hours post procedure
    Title
    Lung Ultrasound Score (LUSS)
    Description
    We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24).
    Time Frame
    before and after block at "90 minutes" then every "24 hours" for 3 days
    Title
    hospital stay
    Description
    time to fill the discharge criteria
    Time Frame
    day for discharge, assessed up to 14 days
    Title
    mean arterial blood pressure
    Description
    mean arterial blood pressure by non invaisive blood pressure monitoring
    Time Frame
    before and after the block every "2hours" for 3 days
    Title
    heart rate
    Description
    heart rate by EKG monitor
    Time Frame
    before and after the block every "2hours" for 3 days
    Title
    peripheral arterial oxygen saturation (SpO2)
    Description
    measured by Pulse oximetry
    Time Frame
    before and after the block every "2hours" for 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads. Exclusion Criteria: significant head injury and unconsciousness (GCS less than 14) Patients with significant pain from other injuries pathological obesity (body mass index ≥35) history of drug allergy local anesthetics local infection at the injection site inability to obtain consent from patient or surrogate, and patient refusal
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohammed mamdouh, master
    Phone
    +201011976368
    Email
    mamdouh372@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
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    Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

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