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Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quadratus Lumborum Block
Caudal Block
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring lower abdominal surgeries, quadratus lumborum block, caudal block

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 1-7 years
  • American Society of Anesthesiologists physical status I-II
  • Lower abdominal surgery

Exclusion Criteria:

  • History of developmental delay or mental retardation
  • Parent refusal
  • History of allergic reactions to local anesthetics
  • Rash or infection at the injection site
  • Anatomical abnormality
  • Bleeding disorders.
  • History of cardiac, neurological, renal, hepatic diseases.

Sites / Locations

  • Fayoum University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum Block (QL)

Caudal block (C)

Arm Description

Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected.

After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%.

Outcomes

Primary Outcome Measures

Time at which the first analgesia required
in hours

Secondary Outcome Measures

Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
number of analgesic doses for each patient
by oral paracetamol 30 mg/kg given by parents
The general satisfaction score of parents
measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.
Preoperative heart rate
in beat per minutes measured by electrocardiogram
Preoperative systolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Preoperative diastolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Intraoperative systolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Intraoperative diastolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Intraoperative heart rate
in beat per minutes measured by electrocardiogram
Incidence of hypotension
drop of blood pressure more than 20 % of baseline blood pressure
Incidence of bradycardia
Heart rate below 50 beat per minute by electrocardiogram
Incidence of vascular puncture
as signs of local anesthetics toxicity
Incidence of convulsions
as signs of local anesthetics toxicity
Incidence of arrhythmias
as signs of local anesthetics toxicity
Incidence of paresthesia
as signs of local anesthetics toxicity
Incidence of hematoma formation
Recorded under ultrasound guidance
Incidence of injury to the underlying structures
Injury to the liver or a viscous

Full Information

First Posted
August 1, 2018
Last Updated
September 5, 2022
Sponsor
Fayoum University Hospital
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03646630
Brief Title
Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia
Official Title
Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital
Collaborators
Cairo 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 aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.
Detailed Description
Regional anesthesia and analgesia techniques are commonly used during pediatric surgical practice to facilitate pain control, decrease parenteral opioid requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. The quadratus lumborum (QL) block is a recently introduced abdominal truncal block, used for somatic and visceral analgesia of both the upper and lower abdomen. It was first described by Blanco in 2007 . Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . QL block allows the local anesthetics to spread between the posterior aspect of the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia, which is close to the thoracic paravertebral space . The ultrasound (US) has gained popularity among anesthesiologists performing regional anesthesia. Block success, and hence the efficacy would depend on the patient's anatomical variations and the anesthesiologist's skill level . The use of ultrasound-guidance for peripheral nerve blocks (PNBs) offers many advantages. Direct visualization of the nervous and surrounding structures decreases the incidence of complications e.g. inadvertent intraneural or intravascular injection. Direct real-time observation of the local anesthetics spread ensures more accurate deposition .This leads to faster onset and longer duration of block, thus improves block quality. It also allows dose reduction of local anesthetics . It has been shown that when peripheral nerves are adequately imaged by ultrasound, the simultaneous use of the nerve stimulator offers no further advantages. Following ethical committee approval of Anesthesia department, Fayoum University and obtaining informed consent from parents of each patient, fifty two patients will be randomized into 2 study groups. Each group contains 26 patients. Methodology: Preoperative Assessment: All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Operating Room Preparation & Equipment: The ultrasound used will be Sonosite M Turbo (USA), the scanning probe will be the linear multi-frequency 13-6 MHz transducer (L25x13-6 MHz linear array). The needle used will be the stimuplex D needles manufactured by B Braun (Germany). Perioperative Management: All patients will be premedicated with IM midazolam 0.2 mg/kg and atropine 0.02 mg/kg. Perioperative monitoring will include continuous ECG, pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring. Inhalational induction of general anesthesia (GA) will be performed with a face mask using sevoflurane 8% and 50% oxygen in air, and then an intravenous (IV) cannula will be inserted. Fentanyl will be administered intravenously at 1 μg/kg, and a laryngeal mask airway (Intavent - Orthofix, Maidenhead, United Kingdom) will be used to secure the upper airway, with the patient kept spontaneously breathing. Anesthesia will be maintained with Isoflurane and 50% oxygen in air. Surgery will be allowed to begin 10 minutes after block application. At the end of surgery, acetaminophen 15 mg/kg IV will be administered to all patients. Any complications occurring during the procedure will be recorded. After completion of surgical procedure and emergence from anesthesia the patient will be referred to PACU. Quality of analgesia will be assessed using a FLACC scale at 30 minutes and at 1, 2, 4, 6, 12, and 24 hours postoperatively. Diclofenac sodium 1 mg/kg rectally will be given as rescue analgesia for patients in all study groups in PACU if FLACC scale > 4. Parents will be informed about the pain evaluation, and when patients had pain at home, parents will be instructed to give oral paracetamol 30 mg/kg. The anesthesiologist will record data received from the parents over the phone. Statistical Analysis Sample size was calculated using the G* Power software version 3.1.7 analysis program (Heinirch Heine University, Dusseldorf, Germany) before the study. Depending on previous similar research with calculated effect size (d) 0.85, two tails (two sided), type 1 error 0.05 and increasing power of study to 90%, it was determined that each group should include at least 26 subject to obtain significant statistical value. Collected data will be computerized and analyzed using statistical package for social science (SPSS) version 16. The results will be expressed as number and percentages for qualitative variables, mean, standard deviation and range for continuous data, median and inter-quartile range for quantitative discrete variables and scores. To compare between groups, the chi-square will be used for qualitative variables, student t rest for comparing quantitative continuous variables between 2 groups, Mann Whitney U test to compare scores between 2 groups. Probability (P) value of less than 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
lower abdominal surgeries, quadratus lumborum block, caudal block

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum Block (QL)
Arm Type
Active Comparator
Arm Description
Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected.
Arm Title
Caudal block (C)
Arm Type
Active Comparator
Arm Description
After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%.
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Caudal Block
Intervention Description
caudal block with 1 ml/kg of bupivacaine 0.25%.
Primary Outcome Measure Information:
Title
Time at which the first analgesia required
Description
in hours
Time Frame
24 hours after procedure
Secondary Outcome Measure Information:
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
30 minutes after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
1 hour after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
2 hours after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
4 hours after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
6 hours after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
12 hours after operation
Title
Pain assessment by the aid of FLACC score
Description
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Time Frame
24 hours after operation
Title
number of analgesic doses for each patient
Description
by oral paracetamol 30 mg/kg given by parents
Time Frame
24 hours after operation
Title
The general satisfaction score of parents
Description
measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.
Time Frame
24 hours after operation
Title
Preoperative heart rate
Description
in beat per minutes measured by electrocardiogram
Time Frame
5 minutes before operation
Title
Preoperative systolic blood pressure
Description
in mm mercury measured by non-invasive blood pressure measurement
Time Frame
5 minutes before operation
Title
Preoperative diastolic blood pressure
Description
in mm mercury measured by non-invasive blood pressure measurement
Time Frame
5 minutes before operation
Title
Intraoperative systolic blood pressure
Description
in mm mercury measured by non-invasive blood pressure measurement
Time Frame
every 15 minutes till end of operation
Title
Intraoperative diastolic blood pressure
Description
in mm mercury measured by non-invasive blood pressure measurement
Time Frame
every 15 minutes till end of operation
Title
Intraoperative heart rate
Description
in beat per minutes measured by electrocardiogram
Time Frame
every 15 minutes till end of operation
Title
Incidence of hypotension
Description
drop of blood pressure more than 20 % of baseline blood pressure
Time Frame
within one hour of the intervention
Title
Incidence of bradycardia
Description
Heart rate below 50 beat per minute by electrocardiogram
Time Frame
Within one hour of the intervention
Title
Incidence of vascular puncture
Description
as signs of local anesthetics toxicity
Time Frame
Within one hour of the intervention
Title
Incidence of convulsions
Description
as signs of local anesthetics toxicity
Time Frame
Within one hour of the intervention
Title
Incidence of arrhythmias
Description
as signs of local anesthetics toxicity
Time Frame
Within one hour of the intervention
Title
Incidence of paresthesia
Description
as signs of local anesthetics toxicity
Time Frame
Within one hour of the intervention
Title
Incidence of hematoma formation
Description
Recorded under ultrasound guidance
Time Frame
Within one hour of the intervention
Title
Incidence of injury to the underlying structures
Description
Injury to the liver or a viscous
Time Frame
Within one hour of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 1-7 years American Society of Anesthesiologists physical status I-II Lower abdominal surgery Exclusion Criteria: History of developmental delay or mental retardation Parent refusal History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding disorders. History of cardiac, neurological, renal, hepatic diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kareem M Nawwar, MD
Organizational Affiliation
Kasr ElAini Hospital, Faculty Of Medicine, Cairo Univerisity
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University hospital
City
Madīnat al Fayyūm
State/Province
Faiyum Governorate
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11460814
Citation
Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
Results Reference
background
PubMed Identifier
22630613
Citation
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.
Results Reference
background
PubMed Identifier
25642956
Citation
Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
Results Reference
background
PubMed Identifier
20216022
Citation
Liu SS, Ngeow J, John RS. Evidence basis for ultrasound-guided block characteristics: onset, quality, and duration. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S26-35. doi: 10.1097/AAP.0b013e3181d266f0.
Results Reference
background
PubMed Identifier
20377542
Citation
Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:1-12. doi: 10.1111/j.1365-2044.2009.06200.x.
Results Reference
background

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Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

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