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出境医 / 临床实验 / Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children

Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children

Study Description
Brief Summary:

To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy.

The primary outcome:

• to compare between caudal block and ultrasound guided quadratus lamborum block.

The secondary outcome:

  • duration of postoperative analgesia.
  • incidence of postoperative complications.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Hernioraphy/Caudal block Procedure: Hernioraphy/Quadratus Lumborum block Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children.
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 11, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Hernioraphy/Caudal block
patients will receive a caudal block after induction of general anaesthesia.
Procedure: Hernioraphy/Caudal block
30 patients will receive a caudal block after induction of general anaesthesia

Active Comparator: Hernioraphy/Quadratus Lumborum block
patients will receive ultrasound guided quadrates lumborum block (QL )
Procedure: Hernioraphy/Quadratus Lumborum block
30 patients will receive ultrasound guided quadrates lumborum block

Outcome Measures
Primary Outcome Measures :
  1. Postoperative pain. [ Time Frame: 24 hours ]
    FLACC Scale from 0 to 10


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.

-

Exclusion Criteria:

Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal

Contacts and Locations

Locations
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Egypt
Alexandria Faculty of Medicine
Alexandria, Egypt, 21111
Sponsors and Collaborators
University of Alexandria
Investigators
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Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD Alexandria University
Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE October 1, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Postoperative pain. [ Time Frame: 24 hours ]
FLACC Scale from 0 to 10
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children
Official Title  ICMJE Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children.
Brief Summary

To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy.

The primary outcome:

• to compare between caudal block and ultrasound guided quadratus lamborum block.

The secondary outcome:

  • duration of postoperative analgesia.
  • incidence of postoperative complications.
Detailed Description

After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed consent from the guardians of each patient, the present study will be carried out in Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.

The sample size was calculated by High Institute of Public Health.

Exclusion Criteria:

Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal

The patients will be randomly divided by closed envelope technique into two groups:

Group I: 30 patients will receive a caudal block after induction of general anaesthesia.

Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL muscles and the thoracolumbar fascia. .

METHOD

Preoperative Assessment:

  1. History taking
  2. Clinical examination
  3. Routine laboratory investigations including complete blood picture, bleeding and clotting time, prothrombin time, partial thromboplastin time, blood urea, serum creatinine and fasting blood sugar will be done to every patient.

Pre anaesthetic preparation and premedication

  • Nothing per mouth for 6 hours before surgery.
  • A peripheral cannula (22 G) will be inserted in all patients.
  • Administration 0f 10ml/kg. lactated Ringer's solution.
  • All patients will be premedicated with atropine 0,1mg/kg. administered IM to all the patients 30 min prior to surgery.

A multi-channel monitor will be attached to the patient to display:

  1. Continuous lead II electro cardiogram (ECG) monitoring.
  2. Non-invasive blood pressure measurement (NIBP) mmHg.
  3. Arterial oxygen saturation by pulse oximeter (SpO2%).
  4. End-tidal capnogram (ETco2).

Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained with sevoflurane 2% and 50% air in oxygen.

  • All procedures (Caudal , QL) will be performed by the same anaesthetist after placement of the LMA before surgery.
  • The patients of both groups were admitted to the ward and receive standard postoperative analgesic regimen composed of regular paracetamol 15mg./kg. every 8hours.

According to the studied group, patients will receive after induction either Group I: caudal block. Group II: Quadratus lamborum block.

Technique:

-For the caudal block, the patients were first inducted by GA and then they were placed in the altered left lateral position. The block site, which was mainly at the sacral hiatus, was sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a 23-gage short needle injection was used with the bevel towards the abdomen to puncture the sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have punctured, the needle was tilted more towards the skin surface and the needle was inserted 2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25% bupivacaine 1 ml/kg was infused. (8,9).

In the QL block group, the probe will be placed anterior and superior to the iliac crest, and the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will be followed posterolaterally until the posterior border of the muscle will be identified. When the probe is tilted to the attachment site of both the internal abdominal oblique muscle and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle will be directed from anterolateral to posteromedial after making a negative aspiration test with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the thoracolumbar fascia(10).

The operation will be planned to begin 7 to 10 minutes after the block is applied , and all patients will be operated on with a standardized technique.

Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability ) behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater ibuprofen 7mg/kg will be administered orally .

Any complications occurring during the procedure will be recorded and treated :

  • Hypotension : In childhood, hypotension can be considered significant when there is 20-30% reduction from baseline in systolic blood pressure ( SBP ) (12) . Treated by administering fluid bolus(13) .
  • Bradycardia : Defined as(14):

< 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine .

• Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) .

MEASURMENTS:

The following parameters will be measured for all patients:

  • Pain levels will be assessed using a FLACC (Face, Legs ,Activity, Cry, Consolability) behavioral pain assessment scale postoperatively after recovery at 30minutes and at 1, 2, 4, 6, 12, and24 hours by the nurses and a second anesthetist will be blinded to groupassignment in the recovery room and the surgical ward .
  • Duration of analgesia measured by time from start of the block to the first request for analgesia .
  • Total analgesic dose .
  • Postoperative complications, such as hypotension, arrhythmia, bradycardia,, nausea, or vomiting .
  • Parent satisfaction. Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10(16).

A-Haemodynamics

  1. Heart rate (beats/minute) and rhythm.
  2. Non-invasive mean arterial blood pressure (MABP) in mm Hg. Timing

    • Baseline: before the block.
    • Just after the block.
    • Every 5 min during surgery.
    • Every 2 hour after surgery.

B-Need for intraoperative rescue analgesia:

Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline values obtained just before surgical incision. An intraoperative increase in blood pressure (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a rescue opioid (fentanyl; 1mcg/kg).

C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120 min. post-surgery, the last pain scores were taken. The pain scores were taken when the patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was infused.

D-Analgesic requirements

  • Total dose of analgesics postoperative will be recorded
  • Time of first analgesic dose given. E-Incidence of postoperative complications: e.g.: nausea , vomiting and respiratory depression.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Procedure: Hernioraphy/Caudal block
    30 patients will receive a caudal block after induction of general anaesthesia
  • Procedure: Hernioraphy/Quadratus Lumborum block
    30 patients will receive ultrasound guided quadrates lumborum block
Study Arms  ICMJE
  • Active Comparator: Hernioraphy/Caudal block
    patients will receive a caudal block after induction of general anaesthesia.
    Intervention: Procedure: Hernioraphy/Caudal block
  • Active Comparator: Hernioraphy/Quadratus Lumborum block
    patients will receive ultrasound guided quadrates lumborum block (QL )
    Intervention: Procedure: Hernioraphy/Quadratus Lumborum block
Publications *
  • Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of "normal" and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8.
  • Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
  • Jöhr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e. Review.
  • Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-81.
  • Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60. Review.
  • Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27. Review.
  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
  • Waldman SD. Caudal epidural nerve block: prone position. In: Atlas of Interventional Pain Management, 2nd edn. Philadelphia: Saunders, 2004 ; 380-92
  • Machotta A, Risse A, Bercker S, Streich R, Pappert D. Comparison between instillation of bupivacaine versus caudal analgesia for postoperative analgesia following inguinal herniotomy in children. Paediatr Anaesth. 2003 Jun;13(5):397-402.
  • Öksüz G, Bilal B, Gürkan Y, Urfalioğlu A, Arslan M, Gişi G, Öksüz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
  • Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
  • Nafiu OO, Voepel-Lewis T, Morris M, Chimbira WT, Malviya S, Reynolds PI, Tremper KK. How do pediatric anesthesiologists define intraoperative hypotension? Paediatr Anaesth. 2009 Nov;19(11):1048-53. doi: 10.1111/j.1460-9592.2009.03140.x. Epub 2009 Oct 1.
  • Pawar D. Common post-operative complications in children. Indian J Anaesth. 2012 Sep;56(5):496-501. doi: 10.4103/0019-5049.103970.
  • Chiu SN, Lin LY, Wang JK, Lu CW, Chang CW, Lin MT, Hua YC, Lue HC, Wu MH. Long-term outcomes of pediatric sinus bradycardia. J Pediatr. 2013 Sep;163(3):885-9.e1. doi: 10.1016/j.jpeds.2013.03.054. Epub 2013 Apr 25.
  • Höhne C. Postoperative nausea and vomiting in pediatric anesthesia. Curr Opin Anaesthesiol. 2014 Jun;27(3):303-8. doi: 10.1097/ACO.0000000000000073. Review.
  • Liversidge XL, Taylor DM, Liu B, Ling SL, Taylor SE. Variables associated with parent satisfaction with their child's pain management. Emerg Med Australas. 2016 Feb;28(1):39-43. doi: 10.1111/1742-6723.12519. Epub 2015 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 11, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.

-

Exclusion Criteria:

Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811392
Other Study ID Numbers  ICMJE 050108018(18/12/2018)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohammad Hazem I. Ahmad Sabry, University of Alexandria
Study Sponsor  ICMJE University of Alexandria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD Alexandria University
PRS Account University of Alexandria
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP