Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.

Study Overview
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Brief Summary
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Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries

Detailed Description
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After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes. Anesthetic Technique: Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure. • After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups. The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected. Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).

Official Title
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Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial

Conditions
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Post Operative Pain, Quadratus Lumborum Block, Pediatric, Abdominal Surgery

Intervention / Treatment
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* Procedure: ultrasound guided quadratus lumborum block
* Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously
* Drug: Bupivacaine Injection
* Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients(6-12 years) ASA physical status I,II Abdominal surgery Exclusion Criteria: Parents refusal or legal guardian's refusal Allergy to bupivacaine or dexamethasone Contraindications to regional techniques Failed QLB Infection on site of procedure

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Quadratus Lumborum Block with dexamethasone IV<br>QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline | Procedure: ultrasound guided quadratus lumborum block<br>* Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach<br>Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously<br>* Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A<br>* Other names: Dexamethasone as an adjuvant intravenously;Drug: Bupivacaine Injection<br>* Bupivacaine will be given to all groups locally with QLB<br>* Other names: Light marcaine;|
| Active Comparator: Group B Quadratus Lumborum Block with dexamethasone locally<br>QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline | Procedure: ultrasound guided quadratus lumborum block<br>* Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach<br>Drug: Bupivacaine Injection<br>* Bupivacaine will be given to all groups locally with QLB<br>* Other names: Light marcaine;Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally<br>* Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B<br>* Other names: Dexamethasone as an adjuvant locally;|
| Placebo Comparator: Group C Quadratus Lumborum Block with bupivacaine alone<br>Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline. | Procedure: ultrasound guided quadratus lumborum block<br>* Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach<br>Drug: Bupivacaine Injection<br>* Bupivacaine will be given to all groups locally with QLB<br>* Other names: Light marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia | using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia. | 24 hours | 
| The duration of analgesia | the time starting from extubation until analgesia will be required as evidenced by a pain score > 4. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total amount of paracetamol doses | paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain | 24 hours | 
| Postoperative vomiting | vomiting and/or retching without expulsion of gastric content will be recorded by a nurse who will be blinded to study conditions. It will treated if vomiting occurred more than twice in 2 minutes with by granisetron | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadratus lumborum block in pediatrics, Dexamethasone