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Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serratus anterior plane block
Erector spinae block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients with American Society of Anesthesiologists (ASA) physical status 1-3 --
  • scheduled for VATS .

Exclusion Criteria:

  1. ≤20 or ≥80 years old.
  2. Refusing to participate in the study .
  3. History of allergy to the medications used in the study.
  4. Contraindication to regional anesthesia (including coagulopathy and local infection).
  5. Severe hepatic impairement (serum protein < 3g/dl and serum bilirubin > 3mg/dl) .
  6. Renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (CLcr)<50ml/min).
  7. Psychiatric disorder.
  8. Pregnancy.
  9. Body mass index (BMI) ≥40 or ≤18 kg/m2.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Serratus anterior block

    Erector spinae block

    Arm Description

    Regional analgesic block of anterolateral chest wall

    Regional analgesic block for the whole chest wall

    Outcomes

    Primary Outcome Measures

    the duration till 1st requirement of analgesia
    The time from the end of the operation till Visual analogue score more than 3

    Secondary Outcome Measures

    Analgesic consumption
    Total analgesic opioid consumption during the first postoperative day

    Full Information

    First Posted
    January 31, 2022
    Last Updated
    February 11, 2022
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05218746
    Brief Title
    Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
    Official Title
    Comparison Between Serratus Anterior Plane Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2022 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to compare serratus anterior plane block and erector spinae plane block for postoperative analgesia after VATS as measured by the duration till 1st requirement of analgesia.
    Detailed Description
    Video-assisted thoracoscopic surgery has become the standard surgical procedure for both minor and major oncological lung surgery, as it is considered less invasive and equally effective compared with thoracotomy . However, it is a fact that pain following VATS can be severe and long-lasting. According to Homma et al., 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery. Serratus anterior plane block is a type of interfascial plane block that was defined by Blanco and his colleagues in 2013 .Ultrasound-guided SAPB has recently gained the interest of the anesthesiologists and pain physicians due to its efficacy, relative ease, single-injection method with limited side-effect profile. The SAPB targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax.These branches of the intercostal nerves, therefore, travel through the two potential spaces described above. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. Erector spinae plane block is an interfascial plane block that was defined by Forero and colleagues in 2016. Erector spinae plane block has a wide indication range for pain management of the thoracic, abdominal , lumbar, hip, and even shoulder areas . Erector spinae plane block is a paraspinal block that targets the dorsal and ventral rami so that it can provide analgesia in the anterolateral and posterior chest wall . Erector spinae plane block emerged in recent years to be effective in reducing postoperative pain at 24 h, i.e. preoperative ESPB plus intravenous opioid reduced pain scores and opioid consumption after VATS when compared with intravenous fentanyl only .

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Serratus anterior block
    Arm Type
    Experimental
    Arm Description
    Regional analgesic block of anterolateral chest wall
    Arm Title
    Erector spinae block
    Arm Type
    Experimental
    Arm Description
    Regional analgesic block for the whole chest wall
    Intervention Type
    Procedure
    Intervention Name(s)
    Serratus anterior plane block
    Intervention Description
    High-frequency linear transducer will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, Then, using ultrasound guidance, the needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib . one millileter normal saline will be injected to confirm placement and to hydro-dissect the fascial layers and open the potential space.
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector spinae block
    Intervention Description
    A high-frequency linear ultrasound probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes is identified, spinal needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle.
    Primary Outcome Measure Information:
    Title
    the duration till 1st requirement of analgesia
    Description
    The time from the end of the operation till Visual analogue score more than 3
    Time Frame
    postoperative first day
    Secondary Outcome Measure Information:
    Title
    Analgesic consumption
    Description
    Total analgesic opioid consumption during the first postoperative day
    Time Frame
    postoperative first day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Patients with American Society of Anesthesiologists (ASA) physical status 1-3 -- scheduled for VATS . Exclusion Criteria: ≤20 or ≥80 years old. Refusing to participate in the study . History of allergy to the medications used in the study. Contraindication to regional anesthesia (including coagulopathy and local infection). Severe hepatic impairement (serum protein < 3g/dl and serum bilirubin > 3mg/dl) . Renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (CLcr)<50ml/min). Psychiatric disorder. Pregnancy. Body mass index (BMI) ≥40 or ≤18 kg/m2.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

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