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Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial

Primary Purpose

Quadratus Lumborum Block, Transversus Abdominis Plane Block, Caudal Block

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propofol
Atracurium Besylate
sevoflurane
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quadratus Lumborum Block

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients of ASA physical status Ӏ or ӀӀ
  • scheduled for inguinal hernia surgery

Exclusion Criteria:

  • lack of consent by parents
  • blood coagulopathies.
  • local infection.
  • vertebral deformity.
  • allergy to drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Quadratus lumborum block group

    Transversus abdominis block group

    Caudal block group

    Arm Description

    will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles.

    will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection.

    will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).

    Outcomes

    Primary Outcome Measures

    The time to first analgesic request
    The time to first analgesic request is recorded by a nurse unaware about the typy of block.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    July 3, 2022
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05442905
    Brief Title
    Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial
    Official Title
    Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    March 1, 2023 (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
    Background: Multimodal analgesia (MMA) is the current standard practice to provide postoperative analgesia. The aim of this study is to compare the analgesic efficacy of quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal block as an adjunct to MMA. Methods: In a prospective, randomized, controlled study, 180 children of age 2 8 years and ASA grade Ӏ and ӀӀ, undergoing elective inguinal hernia surgery will be randomly allocated into 3 groups: Group Q (n = 60) will receive USG guided QL block with 0.7mL/kg of 0.25% bupivacaine and Group C (n = 60) will receive caudal block with 1mL/kg of 0.25% bupivacaine and Group T (n = 60) will receive USG guided TAP block with 0.5mL/kg of 0.25% bupivacaine. Postoperatively, all the subjects will be assessed at 2, 4, 6, 8, 12, 18, and 24 hours. The primary outcome will be the time to first analgesic request. The secondary outcomes will be the pain scores during rest and movement, number of doses of morphine, variation in hemodynamic parameters and adverse effects, if any.
    Detailed Description
    This prospective, randomized, comparative study will be conducted at Tanta University Hospitals from August 2022 to March 2023. Total 180 patients of ASA physical status Ӏ ӀӀ, aged 2-8 years, scheduled for inguinal hernia surgery will be randomized into three groups of 60 patients each, using a computer generated random number table. Exclusion criteria will include lack of consent by parents, blood coagulopathies, local infection, vertebral deformity, and allergy to drugs. Group Q: will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles. Patients in: Group T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection. Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery). All patients will be visited 1 day prior to surgery and will be explained about the anesthesia technique and perioperative course. Each patient will undergo a thorough pre anesthetic check. On arrival in OT, multipara monitoring of ECG, SpO2, NIBP will be established. Base line parameters (SpO2 , pulse rate, SBP, DBP) will be recorded. Patient will be pre medicated with glycopyrrolate 0.005mg/kg, midazolam 0.05mg/kg, and fentanyl 2µg/kg intravenously (IV) through already secured IV line, and ringer lactate infusion will be started. After pre oxygenation with 100% O2 , anesthesia will be induced with propofol 2-3mg/kg and atracurium 0.6mg/kg; endotracheal intubation will be done using appropriate size endotracheal tube. Anesthesia will be maintained with O2 :N2 O ratio 40:60 and sevoflurane(1%-2%) and atracurium 0.15mg/kg SOS. In Group T, patients will be placed in supine position and the abdomen exposed, skin and transducer will be aseptically prepared. The abdominal wall will be scanned using a linear array transducer probe(6-13 MHz) in the multibeam mode, connected to a portable ultrasound unit (S Nerve® SonoSite, Bothell, WA, USA). Probe will be placed in midline over the rectus abdominis muscle at umbilicus level and will be traced laterally to region above the iliac crest to the petit triangle. A 22 G short beveled block needle will be inserted in plane with transducer, in anterior posterior direction. After visualization of needle tip in between internal oblique and transversus abdominis fascial sheath, local anesthetic 0.7mL/kg of bupivacaine 0.25% will be deposited. Correct local anesthetic drug placement will be indicated by hypoechoic elliptical fluid pocket between these two muscles. To maintain blinding, postoperative evaluation of pain scores will be done by an anesthesiologist, who will be not involved in administering block. Postoperative pain will be assessed by CHEOPS score in which six parameters (cry, facial expression, child verbal, torso, touch, and leg movements) are included. Duration of postoperative analgesia, total number of rescue analgesic requirement and total dose of rescue analgesic required in 24h and any side effects (hypotension, bradycardia, respiratory depression, urinary retention, postoperative nausea and vomiting) will be recorded. Pain scores ≥ 6 for rescue analgesia in form of syrup paracetamol 10mg/kg orally will be administered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quadratus Lumborum Block, Transversus Abdominis Plane Block, Caudal Block, Postoperative Pain, Inguinal Hernia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group Q: will receive quadratus lumborum block the patient will be placed in lateral positionGroup T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The 3 analgesic twchniques were described to the parents preoperatively and they will agree to give their child either of them and To maintain blinding, postoperative evaluation of pain scores will be done by an anesthesiologist, who will be not involved in administering block.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Quadratus lumborum block group
    Arm Type
    Active Comparator
    Arm Description
    will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles.
    Arm Title
    Transversus abdominis block group
    Arm Type
    Active Comparator
    Arm Description
    will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection.
    Arm Title
    Caudal block group
    Arm Type
    Active Comparator
    Arm Description
    will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Other Intervention Name(s)
    Intravenous anesthesia
    Intervention Description
    Anesthesia will be induced with propofol 2-3mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Atracurium Besylate
    Other Intervention Name(s)
    Muscle relaxant
    Intervention Description
    Atracurium 0.15mg/kg used for muscle relaxation before intubation
    Intervention Type
    Drug
    Intervention Name(s)
    sevoflurane
    Other Intervention Name(s)
    Inhalational anesthesia
    Intervention Description
    sevoflurane(1%-2%) used during anesthesia
    Primary Outcome Measure Information:
    Title
    The time to first analgesic request
    Description
    The time to first analgesic request is recorded by a nurse unaware about the typy of block.
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients of ASA physical status Ӏ or ӀӀ scheduled for inguinal hernia surgery Exclusion Criteria: lack of consent by parents blood coagulopathies. local infection. vertebral deformity. allergy to drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Authors haven't decided to make individual participant data (IPD) available to other researchers yet.

    Learn more about this trial

    Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial

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