Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.

Study Overview
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Brief Summary
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To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.

Detailed Description
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The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.

Official Title
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Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.

Conditions
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Pain, Acute

Intervention / Treatment
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* Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.
* Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age starting from 5 to 12 years. Genders eligible for study: both sexes. American Society Of Anesthesia (ASA) I-III. Scheduled to undergo laparoscopy. Exclusion Criteria: Refusal of regional block or patients requiring emergency procedures. Known Local Anesthetics drug sensitivity Bleeding disorders with International Normalised Ratio (INR) > 1.5 and/or platelets < 100 000. Skin lesions or wounds at site of proposed needle insertion. Evidence of peritonitis or septicemia. Hepatic disease or enlargement.

Ages Eligible for Study
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Minimum Age: 5 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: age:5-12, American Society of Anesthesia I-III, abdominal laparoscopies, randomly allocated into one of the study groups, randomization sequence will be concealed in sealed envelopes with alphabetic codes. The identifiers will be attached to the opened envelopes and secured by dedicated person independent of randomization proceedings. Patients, parents and data analysts will be blinded to group assignments. The groups: group A → Trans muscular quadrous lamborum block (n=22) group B → Intra muscular quadrous lamborum block (n=22) group c → control (n=22) will receive conventional analgesia. Sample size Starting number of 22 patients for each group, Recalculation of the sample size will be carried out after studying 10 patients per group. The alpha error is set at 0.05 and the study power is 0.95.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trans Muscular Quadratus Lumborum fascial plane Block<br>In group (Trans Muscular Quadratus Lumborum Block),will undergo ultrasound guided trans-muscular quadratus lamborum block as follows: A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoas Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. | Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.<br>* A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoa Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.<br>|
| Active Comparator: Intra Muscular Quadratus Lumborum fascial plane Block<br>In group Intra Muscular Quadratus Lumborum Block ,will undergo ultrasound guided intra-muscular quadratus lamborum (QL) block as follows: A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side. | Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.<br>* A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.<br>|
| Placebo Comparator: group c → control<br>group c → control ,will receive conventional analgesia in the form of paracetamol with 15 mg\ k.g every 6 hours, and naluphin 0.1 mg \kg on demands | Procedure: Control<br>* Conventional analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of the first postoperative analgesic request | (duration of the block, time spent post-operative before rescue opioid is needed at pain score of 6 or higher, up to 12 hours post operative. | starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid consumption over the first 12 hours. | rescue analgesia in the form of intravenous nalbuphine 0.1 milligram/Kilogram will be given for a Wong-Baker Faces Scale more than 4 up to 12 hours post operative. | through out the first 12 hours post operative. | 
| Pain score up to 12 hours after surgery. | Postoperative pain score for each patient will be assessed by Wong-Baker Faces Scale at the following intervals: 15, 30, and 60 min, 6, and 12 hours after surgery. | through out the first 12 hours post operative. | 
| Block failure | a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively | through out the first hour post operative. | 
| Ease of performance of each technique | Easiness of performance of the technique, rated on a simple verbal scale easy/moderately difficult/difficult) and defined as follows: Easy block: successful block after the 1st skin puncture. Moderately difficult block: successful block after more than one puncture or with the need for needle redirection or image optimization (as adjustment of depth, gain, or focus to visualize the needle path) Difficult block: successful block after more than one puncture and with the with the need for needle redirection and image optimization | through out the block performance time | 
| Block performance time | Block performance time in minutes which is the time from probe contact with skin till needle withdrawal | starting from probe contact with skin till 30 minutes. | 
| The incidence of post block adverse effects | incidence of complications, such as: postoperative nausea and vomiting, urinary retention, lower limb weakness injury to the underlying structures (injury to the liver or a viscus), or hematoma formation as recorded under ultrasound guidance need of postoperative mechanical ventilation or ICU admission LA toxicity. | starting after the block is given up to the first 12 hours post operative |