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Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
erector spinae block
thoracic paravertebral block
Pethidine Only Product in Parenteral Dose Form
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring open nephrectomy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients (30-60 years) .
  • Patients with ASA I , II score

Exclusion Criteria:

  • Patient's refusal
  • Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )
  • Infection at the injection site.
  • Allergy to local anesthetics.
  • Patients receiving opioids for chronic analgesic therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    erector spinae arm

    thoracic paravertebral arm

    drug arm

    Arm Description

    ultrasound guided erector spinae block

    ultrasound guided thoracic paravertebral block.

    pethidine (1 mg/kg ) once

    Outcomes

    Primary Outcome Measures

    Total morphine requirements 24 hours postoperatively
    morphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at <3 and the total 24-hours morphine consumption will be recorded

    Secondary Outcome Measures

    Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively
    the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity .no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
    Time span to the first postoperative analgesia
    Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
    operation time
    Duration of the anesthesia and surgery to be documented

    Full Information

    First Posted
    January 9, 2021
    Last Updated
    January 19, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04719507
    Brief Title
    Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy
    Official Title
    Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    the study aims to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block after open nephrectomy surgery.
    Detailed Description
    Open nephrectomy is associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension ,headache ,nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting ,constipation, allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank(T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent anecdotal reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami .According to a previous study, Erector Spinae Plane block has allowed a reduction in opioid consumption and excellent pain control in partial nephrectomy. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic. PVB is effective for pain relief in the thoracic, abdominal and limb regions .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    open nephrectomy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    erector spinae arm
    Arm Type
    Experimental
    Arm Description
    ultrasound guided erector spinae block
    Arm Title
    thoracic paravertebral arm
    Arm Type
    Experimental
    Arm Description
    ultrasound guided thoracic paravertebral block.
    Arm Title
    drug arm
    Arm Type
    Active Comparator
    Arm Description
    pethidine (1 mg/kg ) once
    Intervention Type
    Procedure
    Intervention Name(s)
    erector spinae block
    Other Intervention Name(s)
    erector spinae plane block
    Intervention Description
    ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 3 cm laterally to obtain the appropriate visualization. Under aseptic precautions, the needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine is administered in cephalad and caudal directions.
    Intervention Type
    Procedure
    Intervention Name(s)
    thoracic paravertebral block
    Intervention Description
    ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle is inserted cranial to caudal direction using in-plane approach . After confirming the displacement of pleura with 0.5-1 ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine is administered for the block.
    Intervention Type
    Drug
    Intervention Name(s)
    Pethidine Only Product in Parenteral Dose Form
    Intervention Description
    pethidine (1 mg/kg ) once
    Primary Outcome Measure Information:
    Title
    Total morphine requirements 24 hours postoperatively
    Description
    morphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at <3 and the total 24-hours morphine consumption will be recorded
    Time Frame
    24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively
    Description
    the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity .no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
    Time Frame
    2, 4, 6, 12, 18, and 24 hours postoperatively
    Title
    Time span to the first postoperative analgesia
    Description
    Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
    Time Frame
    calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours
    Title
    operation time
    Description
    Duration of the anesthesia and surgery to be documented
    Time Frame
    from start of anesthesia till the end of surgery , expected from 3-4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients (30-60 years) . Patients with ASA I , II score Exclusion Criteria: Patient's refusal Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 ) Infection at the injection site. Allergy to local anesthetics. Patients receiving opioids for chronic analgesic therapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ezzat ezz
    Phone
    01284994135
    Email
    ezzatramzy627@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karim ghaleb
    Phone
    01007451161
    Email
    karim.ghaleb87@gmail.com

    12. IPD Sharing Statement

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    Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy

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