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Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy

Primary Purpose

Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Ultrasound guided Erector Spinae plane Block (ESPB)
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria:

  • Female patients admitted for modified radical mastectomy surgery.
  • American Society of Anesthesiologists (ASA) physical activity I, II
  • Aged (18 - 65) years

Exclusion Criteria:

  • Patient refusal.
  • Patient with neurological deficit.
  • Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
  • Uncooperative patient.
  • Infection at the block injection site.
  • Patients with a history of allergy to drugs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Ultrasound guided Thoracic Interfascial plane Block (TIFB)

    Ultrasound guided Erector Spinae plane Block (ESPB)

    General anesthesia

    Arm Description

    Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.

    Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).

    Patients will receive general anesthesia only without blocks.

    Outcomes

    Primary Outcome Measures

    Total analgesics consumption in the first 24h after surgery.
    Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).

    Secondary Outcome Measures

    Time to first analgesic request after surgery
    Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg) If VAS ≥ 4 all patient will receive paracetamol 1gm /6h.
    Visual Analogue score (VAS)
    Pain will be assessed after surgery over 24 hour using VAS score where (0 = no pain and 10 = severe pain) at (T 30 min, 2, 4, 6, 12, 18, 24 h), if less than 4 non-steroidal anti-inflammatory will be given (ketorolac 30mg) and if more than 4 intra venous morphine (0.05mg / kg)
    Complications occurrence (hypotension, pneumothorax, bradycardia)
    Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.

    Full Information

    First Posted
    November 22, 2021
    Last Updated
    December 30, 2021
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05176938
    Brief Title
    Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy
    Official Title
    Effect of Preoperative Ultrasound Guided Thoracic Interfascial Plane Block Versus Preoperative Thoracic Erector Spinae Plane Block on Acute and Chronic Pain After Modified Radical Mastectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 10, 2022 (Anticipated)
    Primary Completion Date
    November 24, 2022 (Anticipated)
    Study Completion Date
    November 24, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta 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
    This study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.
    Detailed Description
    Various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics. Ultrasound-guided erector spinae block (ESB) is a regional anesthesia technique; recently described by Forero et al, in management of thoracic neuropathic pain. It became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block. ESB leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery, and T 7 level for abdominal surgeries. Spread of local anesthetic following ESB in the cephalic and caudal directions can lead to analgesia from C7 to L2-3. There have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, Thoracic interfascial plane block including pecto-intercostal fascial plane block (PIFB) and serratus intercostal fascial plane block (SIFB). Thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, Although PIFB and SIFB are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical, Thoracic Interfascial Plane Block, Pain, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound guided Thoracic Interfascial plane Block (TIFB)
    Arm Type
    Experimental
    Arm Description
    Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.
    Arm Title
    Ultrasound guided Erector Spinae plane Block (ESPB)
    Arm Type
    Experimental
    Arm Description
    Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).
    Arm Title
    General anesthesia
    Arm Type
    No Intervention
    Arm Description
    Patients will receive general anesthesia only without blocks.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound guided Thoracic Interfascial plane Block (TIFB)
    Intervention Description
    Patients of the group will be placed supine and elevate arm to the head, Serratus intercostal plane block will be with the probe in the midaxillary line, The subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction after giving 3 ml lidocaine locally. In-plane technique was used until the tip of the needle placed between the serratus anterior muscle and the external intercostals muscle a volume of 20 ml plain bupivacaine will be injected.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound guided Erector Spinae plane Block (ESPB)
    Intervention Description
    The patient will be placed in setting position and a superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation, 3 cm lateral to the T4 spinous process. An 8-cm 22-gauge spinal needle will be inserted in cephalic direction after giving 3 ml lidocaine locally until the needle tip hit the transverse process of T4 under ultrasound image visualization, then the needle will be withdrawn slowly to be within the interfacial plane below the erector spinae muscle, then the anesthetic mixture will be injected here. Successful injection will be evidenced by visible linear free spread (cranially and caudally) of injectate below the muscle.
    Primary Outcome Measure Information:
    Title
    Total analgesics consumption in the first 24h after surgery.
    Description
    Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).
    Time Frame
    24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Time to first analgesic request after surgery
    Description
    Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg) If VAS ≥ 4 all patient will receive paracetamol 1gm /6h.
    Time Frame
    24 hours Postoperative
    Title
    Visual Analogue score (VAS)
    Description
    Pain will be assessed after surgery over 24 hour using VAS score where (0 = no pain and 10 = severe pain) at (T 30 min, 2, 4, 6, 12, 18, 24 h), if less than 4 non-steroidal anti-inflammatory will be given (ketorolac 30mg) and if more than 4 intra venous morphine (0.05mg / kg)
    Time Frame
    24 hours Postoperative
    Title
    Complications occurrence (hypotension, pneumothorax, bradycardia)
    Description
    Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.
    Time Frame
    24 hours Postoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients admitted for modified radical mastectomy surgery. American Society of Anesthesiologists (ASA) physical activity I, II Aged (18 - 65) years Exclusion Criteria: Patient refusal. Patient with neurological deficit. Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs). Uncooperative patient. Infection at the block injection site. Patients with a history of allergy to drugs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Areeg K. Ghalwash, MD
    Phone
    1020103170
    Ext
    +20
    Email
    Areg.kotb@med.tanta.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The supporting data will be available upon a reasonable request from the corresponding author.
    IPD Sharing Time Frame
    one year after the end of the study

    Learn more about this trial

    Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy

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