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Completed

NCT Number: NCT03646630

Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

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.

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Key information

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

quadratus lumborum block

Procedure

Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%

Caudal block

Procedure

caudal block with 1 ml/kg of bupivacaine 0.25%.

Primary outcomes

  1. Time at which the first analgesia required

    Time frame: 24 hours after procedure

    in hours

Secondary outcomes

  1. Pain assessment by the aid of FLACC score

    Time frame: 30 minutes after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  2. Pain assessment by the aid of FLACC score

    Time frame: 1 hour after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  3. Pain assessment by the aid of FLACC score

    Time frame: 2 hours after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  4. Pain assessment by the aid of FLACC score

    Time frame: 4 hours after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  5. Pain assessment by the aid of FLACC score

    Time frame: 6 hours after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  6. Pain assessment by the aid of FLACC score

    Time frame: 12 hours after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  7. Pain assessment by the aid of FLACC score

    Time frame: 24 hours after operation

    F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score

  8. number of analgesic doses for each patient

    Time frame: 24 hours after operation

    by oral paracetamol 30 mg/kg given by parents

  9. The general satisfaction score of parents

    Time frame: 24 hours after operation

    measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.

  10. Preoperative heart rate

    Time frame: 5 minutes before operation

    in beat per minutes measured by electrocardiogram

  11. Preoperative systolic blood pressure

    Time frame: 5 minutes before operation

    in mm mercury measured by non-invasive blood pressure measurement

  12. Preoperative diastolic blood pressure

    Time frame: 5 minutes before operation

    in mm mercury measured by non-invasive blood pressure measurement

  13. Intraoperative systolic blood pressure

    Time frame: every 15 minutes till end of operation

    in mm mercury measured by non-invasive blood pressure measurement

  14. Intraoperative diastolic blood pressure

    Time frame: every 15 minutes till end of operation

    in mm mercury measured by non-invasive blood pressure measurement

  15. Intraoperative heart rate

    Time frame: every 15 minutes till end of operation

    in beat per minutes measured by electrocardiogram

  16. Incidence of hypotension

    Time frame: within one hour of the intervention

    drop of blood pressure more than 20 % of baseline blood pressure

  17. Incidence of bradycardia

    Time frame: Within one hour of the intervention

    Heart rate below 50 beat per minute by electrocardiogram

  18. Incidence of vascular puncture

    Time frame: Within one hour of the intervention

    as signs of local anesthetics toxicity

  19. Incidence of convulsions

    Time frame: Within one hour of the intervention

    as signs of local anesthetics toxicity

  20. Incidence of arrhythmias

    Time frame: Within one hour of the intervention

    as signs of local anesthetics toxicity

  21. Incidence of paresthesia

    Time frame: Within one hour of the intervention

    as signs of local anesthetics toxicity

  22. Incidence of hematoma formation

    Time frame: Within one hour of the intervention

    Recorded under ultrasound guidance

  23. Incidence of injury to the underlying structures

    Time frame: Within one hour of the intervention

    Injury to the liver or a viscous

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Collaborators

  • Cairo University

Registry information

Official study title

Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2018
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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