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Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children

Primary Purpose

Postoperative Pain, Acute

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ultrasound-guided Erector Spinae Plane Block
Ultrasound-guided Quadratus Lumborum Block
Ultrasound Machine
Echogenic needle
Fentanyl
Pethidine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain, Acute

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American society of anesthesiologists (ASA) class I and II
  2. Children undergoing unilateral open renal surgeries

Exclusion Criteria:

  1. Parents refusal for the block
  2. Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
  3. Skin lesion, wounds or infection at the puncture site.
  4. Known allergy to local anesthetic drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Erector spinae plane block (ESPB) group

    Quadratus lumborum block (QLB) group

    Arm Description

    30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%

    30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%

    Outcomes

    Primary Outcome Measures

    Time to first postoperative rescue analgesia
    Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).

    Secondary Outcome Measures

    Total opioid analgesic consumption in the first 12 hours postoperative period
    when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
    Intraoperative mean arterial blood pressure
    measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
    Intraoperative heart rate
    measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
    Postoperative pain score
    measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
    Block performance time
    Time to perform ultrasound guided nerve block

    Full Information

    First Posted
    May 8, 2022
    Last Updated
    May 19, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05386121
    Brief Title
    Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
    Official Title
    Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 20, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use. Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block. Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks. In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Acute

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Erector spinae plane block (ESPB) group
    Arm Type
    Active Comparator
    Arm Description
    30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
    Arm Title
    Quadratus lumborum block (QLB) group
    Arm Type
    Active Comparator
    Arm Description
    30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided Erector Spinae Plane Block
    Intervention Description
    Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique. The spread of the injectate will be observed to distribute within this plane.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided Quadratus Lumborum Block
    Intervention Description
    Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it. The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique. The spread of the injectate will be observed to distribute within the target plane.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound Machine
    Intervention Description
    Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
    Intervention Type
    Device
    Intervention Name(s)
    Echogenic needle
    Intervention Description
    A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
    Intervention Type
    Drug
    Intervention Name(s)
    Pethidine
    Intervention Description
    Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
    Primary Outcome Measure Information:
    Title
    Time to first postoperative rescue analgesia
    Description
    Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
    Time Frame
    12 hours
    Secondary Outcome Measure Information:
    Title
    Total opioid analgesic consumption in the first 12 hours postoperative period
    Description
    when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
    Time Frame
    from time of patient transfer to the PACU, till 12 hours postoperatively
    Title
    Intraoperative mean arterial blood pressure
    Description
    measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
    Time Frame
    During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
    Title
    Intraoperative heart rate
    Description
    measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
    Time Frame
    During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
    Title
    Postoperative pain score
    Description
    measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
    Time Frame
    from time of patient transfer to the PACU, till 12 hours postoperatively
    Title
    Block performance time
    Description
    Time to perform ultrasound guided nerve block
    Time Frame
    Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
    Other Pre-specified Outcome Measures:
    Title
    Indirect signs of local anesthetic toxicity
    Description
    intraoperative arrhythmias and delayed awakening
    Time Frame
    from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American society of anesthesiologists (ASA) class I and II Children undergoing unilateral open renal surgeries Exclusion Criteria: Parents refusal for the block Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%) Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kareem MA Nawwar, M.D.
    Phone
    +201003878369
    Email
    drknawwar@cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nevine M Gouda
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sherif M Soaida
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ismail S Hammad
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ahmed T Bahnaswy
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children

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