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Erector Spinae Plane Block vs Paravertebral Block for Pain Management in Fractured Ribs

Primary Purpose

Rib Fracture Multiple

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Paravertebral Block
Sponsored by
Assiut University
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:

  • All patients aged 18 years old or more.
  • Rib Fracture Score 7 or more.
  • American Society of Anesthesiologist's physiologic state II-III patients.
  • 3-6 consecutive fractured ribs.

Exclusion Criteria:

  • Patients who are unable to communicate effectively.
  • Sternal fractures.
  • Bilateral rib fractures.
  • VAS score < 7.
  • Preexisting spinal deformity.
  • Local sepsis at site of injection.
  • Coagulopathy.
  • Known allergy to the local anesthetic used in the study.
  • Patients having significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    TPVB

    ESPB

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in visual pain score
    0 meaning no pain at all, and 10 described as the worst pain experienced.
    Change in Diaphragmatic excursion
    Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it. The provider then percusses down their back in the intercostal margins (bone will be dull), starting below the scapula, until sounds change from resonant to dull (lungs are resonant, solid organs should be dull). That is where the provider marks the spot. Then the patient takes a deep breath in and holds it as the provider percusses down again, marking the spot where the sound changes from resonant to dull again. Then the provider will measure the distance between the two spots.

    Secondary Outcome Measures

    Opioid dose used for 24-hour period after the procedure.

    Full Information

    First Posted
    March 14, 2019
    Last Updated
    March 19, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03883958
    Brief Title
    Erector Spinae Plane Block vs Paravertebral Block for Pain Management in Fractured Ribs
    Official Title
    Comparison of Thoracic Erector Spinae Plane Block With Thoracic Paravertebral Block for Pain Management in Patients With Unilateral Multiple Fractured Ribs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    January 2020 (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
    Rib fractures pose a significant healthcare burden with its associated morbidity, long term disability, and mortality. Pulmonary morbidity is increased in these patients as a result of diminished gas exchange from fracture induced pulmonary injury and from inadequate analgesia compromising both ventilation and pulmonary mechanics. Adequate analgesia is paramount in enhancing pulmonary hygiene aimed at preventing atelectasis and pneumonia. Numbing the nerves to the fractured ribs by injecting local anaesthetic (LA) improves breathing and reduces the risk of complications. Two techniques of regional anesthesia (erector spinae plane block (ESPB) and paravertebral block (PVB)) will be compared regarding their efficacy for treating pain caused by rib fractures. The LA is injected near nerves at two different locations. The PVB is immediately adjacent to the vertebrae, whereas the ESPB is slightly further away from the midline. Both techniques use ultrasound to ensure the LA is directed to the intended place. Adult patients with > 3 consecutive fractured ribs will be consented, then randomised to receive either a ESPB or a PVB. It is expected that both groups will significantly improve in terms of pain score, opioids need, and breathing ability, however it is unclear which technique will provide better results and less complications.
    Detailed Description
    Rib fractures occur most commonly because of blunt thoracic trauma and occur in up to 12% of all trauma patients. Rib fractures themselves pose a significant healthcare burden with its associated morbidity, long term disability, and mortality. Pulmonary morbidity is increased in these patients as a result of diminished gas exchange from fracture induced pulmonary injury and from inadequate analgesia compromising both ventilation and pulmonary mechanics. Various factors affect outcome and mortality after rib fractures. These include the number of ribs fractured, preexisting comorbidities, advanced age, and level of associated pain. Of these, pain is a significant modifiable factor. Adequate analgesia is paramount in enhancing pulmonary hygiene aimed at preventing atelectasis and pneumonia. Systemic analgesia is usually sufficient in younger patients with fewer undisplaced fractures without a flail segment. Regional techniques are particularly useful in elderly patients (>65 years of age), patients with multiple rib fractures (MRFs), and in patients with severe pain or compromised pulmonary function. Conventional regional techniques used to manage rib fractures include epidural analgesia, paravertebral block (PVB), intercostal, and intrapleural block. In 2010 Truitt et al. introduced a novel technique whereby local anesthetic (LA) infiltration superficial to the posterior ribs via tunneled catheters successfully controlled rib fracture pain. Since then, multiple thoracic RA (Regional Anesthesia) techniques have been developed that use ultrasound-guided (USG) LA (local anesthetic) injections into fascial planes from the thoracic spinal lamina to the sternum to anesthetize various regions of the thorax. Some of the conventional regional techniques, particularly epidural analgesia and PVB, may not be feasible in the presence of anticoagulation, multisystem trauma, or in patients unable to be optimally positioned. Recently, several ultrasound-guided (USG) myofascial plane blocks (both single injection and continuous catheter techniques) have been described (e.g. The serratus anterior plane (SAP) block and the erector spinae plane (ESP) block) , which offer the advantages of being less invasive technique and provide adequate analgesia after rib fractures. ESP block is a novel myofascial plane block recently introduced into clinical practice. It has been successfully utilized in the management of pain after both rib fractures and surgery of the abdomen and thorax, and in the management of chronic thoracic pain. In contrast to the SAP block, the ESP block has the ability to provide analgesia to both the anterior and posterior hemithorax, making it particularly useful in the management of pain after extensive thoracic surgery or trauma (anterior, lateral, and posterior chest wall). Innervation of the ribs and adjoining tissue is primarily through thoracic spinal nerves. After emerging from the spinal cord and traversing through the intervertebral foramina, the thoracic spinal nerves split into ventral and dorsal rami. The ventral rami continue as intercostal nerves innervating the lateral and anterior chest wall, whereas the dorsal rami innervate the posterior chest wall after exiting the paravertebral space. The ESP block is directed at the erector spinae myofascial plane, which is located on the posterior chest wall between the anterior surface of the erector spinae muscle and oriented cephalocaudally to the posterior surface of the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami as they traverse the erector spinae plane, producing anesthesia to the posterior hemithorax. Local anaesthetic also spreads anteriorly and cephalocaudally in the erector spinae plane. Ventral rami and intercostal nerves are blocked by anterior spread, providing analgesia to ribs and periosteum as well as large cutaneous areas of the lateral and anterior chest wall (by blockade of lateral and anterior branches of the intercostal nerves). Cephalocaudal spread provides anesthesia to at least three segments above and four segments below the injection site; a single injection can result in extensive thoracic anesthesia. PVB has been shown to be as effective as epidural analgesia in managing multiple rib fractures (MRFs). A recent randomized trial has shown that PVB is superior to intravenous patient-controlled analgesia (IVPCA) in providing better analgesia and improving pulmonary function with MRFs. Unilateral sensory, motor, and sympathetic block can be achieved when local anaesthetic is injected into the paravertebral space. As this space communicates with the intercostal space laterally and the epidural space medially, a 5-6 dermatome sensory block is possible with a single injection of 20 ml of local anaesthetic. Compared with epidural analgesia, PVB is relatively easy to perform, produces less sympathetic blockade, does not cause urinary retention or pruitis, and allows for an unimpeded neurological assessment. However, there is a small risk for pneumothorax, vascular puncture, pleural puncture and a possibility of toxicity due to the rapid absorption of Local Anaesthetic. TPB can be given by using surface landmarks, nerve stimulator guidance or Ultrasound Guidance (USG). A review suggested that USG blocks are more successful and safe than other techniques.

    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
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TPVB
    Arm Type
    Active Comparator
    Arm Title
    ESPB
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector Spinae Plane Block
    Intervention Description
    ESPB will be performed in sitting or lateral decubitus position. The target vertebral level will be correspond to the approximate mid-point of the extent of fractured ribs. The tip of the transverse process of the target vertebra will be identified using the high-frequency linear placed in cephalocaudal orientation about 3 cm to the spinous process. The skin and subcutaneous tissue will be infiltrated with 2-3 ml of 2% lignocaine. With the transducer fixed over the targeted TP, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be advanced in-plane to the ultrasound beam in a cephalo-caudal direction to contact the TP. Correct needle tip position will be confirmed by doing alternating aspiration to confirm lack of inadvertent vascular puncture with injection of 1-2 ml of saline and visualizing linear fluid spread deep to erector spinae muscle, separating it from the TP. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.
    Intervention Type
    Procedure
    Intervention Name(s)
    Paravertebral Block
    Intervention Description
    TPVB will be performed at a spinal level midway between the uppermost and the lowest fractured rib with the patient in sitting or lateral decubitus position (with patients lying on their unaffected side). The ultrasound-guided technique will be used. A high-frequency linear transducer will be used to confirm the levels of the fractured ribs. The most cephalad and most caudad fractured ribs will be identified first. The fractured rib in the middle will be then identified, and the rib will be then traced back medially. After skin and subcutaneous tissue infiltration with 2-3 ml of 2% lignocaine, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be inserted in a lateral-to-medial direction until the needle tip entered the paravertebral space. 1-2 ml of Saline will be injected into the paravertebral space while observing the pleura being moved deeply. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.
    Primary Outcome Measure Information:
    Title
    Change in visual pain score
    Description
    0 meaning no pain at all, and 10 described as the worst pain experienced.
    Time Frame
    Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention
    Title
    Change in Diaphragmatic excursion
    Description
    Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it. The provider then percusses down their back in the intercostal margins (bone will be dull), starting below the scapula, until sounds change from resonant to dull (lungs are resonant, solid organs should be dull). That is where the provider marks the spot. Then the patient takes a deep breath in and holds it as the provider percusses down again, marking the spot where the sound changes from resonant to dull again. Then the provider will measure the distance between the two spots.
    Time Frame
    Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention.
    Secondary Outcome Measure Information:
    Title
    Opioid dose used for 24-hour period after the procedure.
    Time Frame
    24 hour after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients aged 18 years old or more. Rib Fracture Score 7 or more. American Society of Anesthesiologist's physiologic state II-III patients. 3-6 consecutive fractured ribs. Exclusion Criteria: Patients who are unable to communicate effectively. Sternal fractures. Bilateral rib fractures. VAS score < 7. Preexisting spinal deformity. Local sepsis at site of injection. Coagulopathy. Known allergy to the local anesthetic used in the study. Patients having significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Ahmed
    Phone
    +201141987289
    Email
    mohamed0youssefahmed91@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Ahmed
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Erector Spinae Plane Block vs Paravertebral Block for Pain Management in Fractured Ribs

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