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Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

Primary Purpose

Post-thoracotomy Pain Syndrome, Erector Spinae Plane Block, Serratus Anterior Plane Block

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic epidural infusion
Erector Spinae Plane Block
Serratus Anterior Plane Block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-thoracotomy Pain Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age (18-65) Years
  • Physical status American Society of Anesthesiologists Classification II, III
  • Patients undergoing lobectomy through lateral thoracotomy
  • Body mass index (BMI): (20-40) kg/m2

Exclusion Criteria:

  • Patient refusal.
  • Age <18 years or >65 years
  • Body mass index (BMI) <20 kg/m2 and >40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
  • Pregnancy.
  • Physical status American Society of Anesthesiologists Classification IV
  • patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • patients with a history of drug abuse
  • patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
  • patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
  • All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
  • Thoracic spine disorders or deformity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Thoracic epidural infusion group

    Erector Spinae Plane Block group

    Serratus Anterior Plane Block group

    Arm Description

    Patients will receive thoracic epidural preoperative

    Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter

    Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.

    Outcomes

    Primary Outcome Measures

    Incidence of patients developing post-thoracotomy pain syndrome
    The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP

    Secondary Outcome Measures

    Morphine consumption
    The total amount of morphine consumed postoperatively for 48 hours.
    Fentanyl consumption
    Total amount of fentanyl consumed intraoperative
    Post-thoracotomy pain syndrome severity
    Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
    Patient's Quality of life
    Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
    Postoperative Patient's activity level
    Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
    Heart rate
    Heart rate will be recorded
    Mean arterial blood pressure
    Mean arterial blood pressure will be recorded
    Nausea and vomiting
    Postoperative nausea and vomiting (PONV) will be recorded
    Post-operative pain
    Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
    Time taken till 1st rescue analgesic request
    The time till administration of first rescue analgesia will be recorded
    Postoperative pulmonary complications
    Postoperative pulmonary complications will be recorded

    Full Information

    First Posted
    June 3, 2022
    Last Updated
    June 3, 2022
    Sponsor
    National Cancer Institute, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05409144
    Brief Title
    Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
    Official Title
    Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Cancer Institute, Egypt

    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 aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.
    Detailed Description
    Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies. The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas. The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-thoracotomy Pain Syndrome, Erector Spinae Plane Block, Serratus Anterior Plane Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    111 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thoracic epidural infusion group
    Arm Type
    Experimental
    Arm Description
    Patients will receive thoracic epidural preoperative
    Arm Title
    Erector Spinae Plane Block group
    Arm Type
    Experimental
    Arm Description
    Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter
    Arm Title
    Serratus Anterior Plane Block group
    Arm Type
    Experimental
    Arm Description
    Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thoracic epidural infusion
    Intervention Description
    Upon locating the desired site spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle. Once achieving local anesthesia, the epidural needle advanced with its stylet in place and with its bevel point cephalad; this will ultimately contribute to the proper location of the epidural catheter. The epidural needle must be advanced through the skin, subcutaneous tissue, supraspinous, and interspinous ligaments. Once there, the stylet must be removed, and the Loss of Resistance syringe (filled up with saline, air, or both) must be attached to the needle. The needle must be advanced while applying pressure to the plunger. Once the ligamentum flavum is pierced, a loss in resistance will be noted; this is the epidural space, and 5 to 10 cc of saline is injected to expand the epidural space; this may decrease the risk of vascular injury.
    Intervention Type
    Device
    Intervention Name(s)
    Erector Spinae Plane Block
    Intervention Description
    The block-level will be at T5. The ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. 3ml lidocaine 1% will be used on skin and subcutaneous fat, Echogenic block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process.
    Intervention Type
    Device
    Intervention Name(s)
    Serratus Anterior Plane Block
    Intervention Description
    The block is performed with full aseptic precautions. Arm abduction is preferred. The ultrasound probe 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, 3ml lidocaine 1% will be used for skin and subcutaneous fat, using ultrasound guidance, a 38-mm 22-gauge regional block needle is going to be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep into the serratus anterior muscle.
    Primary Outcome Measure Information:
    Title
    Incidence of patients developing post-thoracotomy pain syndrome
    Description
    The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
    Time Frame
    12 weeks postoperatively
    Secondary Outcome Measure Information:
    Title
    Morphine consumption
    Description
    The total amount of morphine consumed postoperatively for 48 hours.
    Time Frame
    48 hours Postoperatively
    Title
    Fentanyl consumption
    Description
    Total amount of fentanyl consumed intraoperative
    Time Frame
    Intraoperatively
    Title
    Post-thoracotomy pain syndrome severity
    Description
    Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
    Time Frame
    12 weeks postoperatively
    Title
    Patient's Quality of life
    Description
    Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
    Time Frame
    12 weeks postoperatively
    Title
    Postoperative Patient's activity level
    Description
    Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
    Time Frame
    12 weeks postoperatively
    Title
    Heart rate
    Description
    Heart rate will be recorded
    Time Frame
    Intraoperatively
    Title
    Mean arterial blood pressure
    Description
    Mean arterial blood pressure will be recorded
    Time Frame
    Intraoperatively
    Title
    Nausea and vomiting
    Description
    Postoperative nausea and vomiting (PONV) will be recorded
    Time Frame
    24 hours postopertivley
    Title
    Post-operative pain
    Description
    Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
    Time Frame
    24 hours postopratively
    Title
    Time taken till 1st rescue analgesic request
    Description
    The time till administration of first rescue analgesia will be recorded
    Time Frame
    24 hours postopratively
    Title
    Postoperative pulmonary complications
    Description
    Postoperative pulmonary complications will be recorded
    Time Frame
    24 hours postopratively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age (18-65) Years Physical status American Society of Anesthesiologists Classification II, III Patients undergoing lobectomy through lateral thoracotomy Body mass index (BMI): (20-40) kg/m2 Exclusion Criteria: Patient refusal. Age <18 years or >65 years Body mass index (BMI) <20 kg/m2 and >40 kg/m2 Known sensitivity or contraindication to drugs used in the study Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy. Pregnancy. Physical status American Society of Anesthesiologists Classification IV patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain) patients with a history of drug abuse patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months. All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study. Thoracic spine disorders or deformity.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abdelfattah, M.Sc
    Phone
    1222332541
    Ext
    +20
    Email
    Dr.ahmed.sha3ban@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data will be available under a reasonable request from the author
    IPD Sharing Time Frame
    One year after the study is ended

    Learn more about this trial

    Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

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