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Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transversalis fascia plane (TFP) block
Erector Spinae Plane (ESP) Block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old

Exclusion Criteria:

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
  • Altered cognitive function
  • Body mass index (BMI > 35 kg/m2)
  • Patients who have difficulty understanding the study protocol
  • Patients who have any known allergy to study medications
  • Advanced hepatic or renal failure
  • Chronic opioid consumption
  • Patient refusal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Transversalis fascia plane (TFP) block

    Erector Spinae Plane (ESP) Block

    Arm Description

    Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision

    Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision

    Outcomes

    Primary Outcome Measures

    The intensity of postoperative pain
    Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 30, 2022
    Last Updated
    September 30, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05565365
    Brief Title
    Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair
    Official Title
    Ultrasound-guided Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Post-operative Analgesia in Inguinal Hernia Repair Under General Anesthesia: a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 14, 2022 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    December 15, 2023 (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
    Uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.
    Detailed Description
    Inguinal hernia repair is one of the most common surgical procedures in the world. Annually, more than 20 million inguinal hernia repairs are conducted worldwide. Uncontrolled postoperative pain increases the incidence of postoperative complications. Regional blocks, as a part of multimodal analgesia, can improve pain control in the postoperative period and reduce complications that may arise from using a single mode of analgesia. For example, reliance on opioid analgesia increases the incidence of pruritus, nausea, and vomiting, as well as respiratory depression. Hebbard first described the ultrasound (US)-guided transversalis fascia plane (TFP) block in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves. Erector spinae plane block (ESPB) is a type of facial plane block in which local anesthetic is administered in the plane located between the erector spinae muscle and thoracic transverse process. ESPB blocks the transmission of nociceptive stimuli through the dorsal/ventral rami of the spinal nerve roots, prevents afferent stimuli transmission, and inhibits efferent activation of the sympathetic nervous system and can thus provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery.The effect of ESPB is also achieved through the block of the lateral, posterior, and anterior thoracic wall resulting in multiple levels sensory blocks. Additional proposed mechanism of action could be explained by the epidural spread of the anesthetics.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transversalis fascia plane (TFP) block
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision
    Arm Title
    Erector Spinae Plane (ESP) Block
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision
    Intervention Type
    Procedure
    Intervention Name(s)
    Transversalis fascia plane (TFP) block
    Other Intervention Name(s)
    TFP block
    Intervention Description
    Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector Spinae Plane (ESP) Block
    Other Intervention Name(s)
    ESP Block
    Intervention Description
    Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision
    Primary Outcome Measure Information:
    Title
    The intensity of postoperative pain
    Description
    Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old Exclusion Criteria: Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis) Altered cognitive function Body mass index (BMI > 35 kg/m2) Patients who have difficulty understanding the study protocol Patients who have any known allergy to study medications Advanced hepatic or renal failure Chronic opioid consumption Patient refusal
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seham M. Moeen, MD
    Phone
    01006386324
    Ext
    02
    Email
    seham.moeen@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Israa M. Abd El-Rahman, Msc
    Phone
    01060019510
    Ext
    02
    Email
    israamohamedvip@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair

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