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The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain

Primary Purpose

Hernia, Inguinal

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Bupivacaine
Dexamethasone
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring nerve block

Eligibility Criteria

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

Inclusion Criteria: Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair Exclusion Criteria: Patient refusal. Body mass index (BMI) >40 kg m2. The presence of skin infection at the injection site. Allergy to local anesthetic drugs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Patients will receive 10 ml of 0.5% bupivacaine

    Patients will receive 10 ml of 0.25% bupivacaine

    Arm Description

    A 2mg dexamethasone will be added

    A 2mg dexamethasone will be added

    Outcomes

    Primary Outcome Measures

    The time to first request for rescue analgesia.
    if score is ≥ 3 analgesia needed

    Secondary Outcome Measures

    The post-operative pain in the form of NRS.
    The total 24 hour opioid consumption
    The incidence of complication related to nerve block
    urinary retention, hematoma, hypotension and arrhythmia
    Patient satisfaction
    in the form of 4 point satisfaction questionnaire: where 1 would be satisfied, 2=neutral, 3=dissatisfied, and 4=extremely dissatisfied.

    Full Information

    First Posted
    January 9, 2023
    Last Updated
    January 17, 2023
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05687981
    Brief Title
    The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain
    Official Title
    The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    January 2024 (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
    The present study will be undertaken to compare the postoperative analgesic effect of 0.25% bupivacaine and 0.5% bupivacaine for unilateral ilioinguinal and Iliohypogastric nerve block after open inguinal hernia repair. Primary outcome: The time to first request for rescue analgesia. Secondary outcome: The post-operative pain in the form of NRS scores at rest & during movement at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure. The total 24 hour opioid consumption. The incidence of complication related to nerve block (urinary retention, hematoma, hypotension and arrhythmia). Patient satisfaction
    Detailed Description
    Postoperative pain is a common complication that may cause a neuroendocrine stress response, which is characterized by increased release of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system. Excessive postoperative pain and the physiological stress response can influence postoperative outcomes, length of hospital stay and overall costs of hospital care Inguinal herniorrhaphy is a common outpatient surgical procedure with approximately 20 million operations performed worldwide annually. Patients undergoing this procedure often experience moderate-to-severe pain, which can hinder post anesthesia care unit (PACU) discharge. While pain can be treated with opioid therapy, the literature supports that opioids may cause postoperative nausea, vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional block has been shown to decrease the previous complications. There is an ongoing interest in developing regional anesthetic techniques that may reduce or eliminate the use of opioid analgesics after minor surgical procedures such as hernia repair. Regional analgesia has found wide acceptance both by the patients and their treating physicians, and therefore, it is now an important part of multimodal analgesia techniques. Ilioinguinal/iliohypogastric nerve block(IINB),transversus abdominis plane (TAP) block, paravertebral and rectus sheath, have all been used for providing analgesia following abdominal surgeries . The combined ilioinguinal and iliohypogastric nerve block (IINB) is a commonly used technique for blockade of the ilioinguinal/iliohypogastric (IIIH) nerves and has been shown to decrease pain after OIH as well as reduce opioid requirements. Bupivacaine belongs to the amide family, and its structure is similar to that of lidocaine. Bupivacaine is a potent agent capable of producing prolonged anesthesia. Its long duration of action plus its tendency to provide more sensory than motor block has made it a popular drug for providing prolonged analgesia during the postoperative period. We assume that the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of post-operative analgesia and patient satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Inguinal
    Keywords
    nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients will receive 10 ml of 0.5% bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    A 2mg dexamethasone will be added
    Arm Title
    Patients will receive 10 ml of 0.25% bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    A 2mg dexamethasone will be added
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of postoperative analgesia
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    2 mg dexamethasone
    Primary Outcome Measure Information:
    Title
    The time to first request for rescue analgesia.
    Description
    if score is ≥ 3 analgesia needed
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    The post-operative pain in the form of NRS.
    Time Frame
    at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.
    Title
    The total 24 hour opioid consumption
    Time Frame
    24 hours
    Title
    The incidence of complication related to nerve block
    Description
    urinary retention, hematoma, hypotension and arrhythmia
    Time Frame
    48 hours
    Title
    Patient satisfaction
    Description
    in the form of 4 point satisfaction questionnaire: where 1 would be satisfied, 2=neutral, 3=dissatisfied, and 4=extremely dissatisfied.
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair Exclusion Criteria: Patient refusal. Body mass index (BMI) >40 kg m2. The presence of skin infection at the injection site. Allergy to local anesthetic drugs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mariam Elkasass
    Phone
    00201024234668
    Email
    mariam160758_pg@med.tanta.ed
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alaa Abohager
    Phone
    00201099220281
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Abduallah
    Organizational Affiliation
    Tanta University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    2265166
    Citation
    Bugedo GJ, Carcamo CR, Mertens RA, Dagnino JA, Munoz HR. Preoperative percutaneous ilioinguinal and iliohypogastric nerve block with 0.5% bupivacaine for post-herniorrhaphy pain management in adults. Reg Anesth. 1990 May-Jun;15(3):130-3.
    Results Reference
    background
    PubMed Identifier
    29720755
    Citation
    Kamal K, Jain P, Bansal T, Ahlawat G. A comparative study to evaluate ultrasound-guided transversus abdominis plane block versus ilioinguinal iliohypogastric nerve block for post-operative analgesia in adult patients undergoing inguinal hernia repair. Indian J Anaesth. 2018 Apr;62(4):292-297. doi: 10.4103/ija.IJA_548_17.
    Results Reference
    background

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    The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain

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