Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics

Study Overview
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Brief Summary
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The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.

Detailed Description
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Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period. Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.

Official Title
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Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial

Conditions
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Ultrasound, Pediatrics, Laparoscopic, Inguinal Hernia Repair, Transversus Abdominis Plane Block, Laparoscopic Intraperitoneal Instillation

Intervention / Treatment
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* Procedure: Ultrasound-guided transversus abdominis plane block
* Procedure: Laparoscopic-assisted transversus abdominis plane block
* Procedure: Laparoscopic-assisted intraperitoneal instillation
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 2 months to 7 years old Both sexes. American Society of Anesthesiologists (ASA) I-II. Schedule for elective unilateral inguinal hernia repair. Exclusion Criteria: Patients with history of allergy. Hepatic and renal failure. Previous inguinal surgery. Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided transversus abdominis plane block<br>This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group. | Procedure: Ultrasound-guided transversus abdominis plane block<br>* This group will receive ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.<br>Drug: Bupivacaine<br>* bupivacaine<br>|
| Experimental: Laparoscopic-assisted transversus abdominis plane block<br>Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL. | Procedure: Laparoscopic-assisted transversus abdominis plane block<br>* Patients will receive laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.<br>Drug: Bupivacaine<br>* bupivacaine<br>|
| Experimental: Laparoscopic-assisted intraperitoneal instillation<br>This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation. | Procedure: Laparoscopic-assisted intraperitoneal instillation<br>* This group will receive laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.<br>Drug: Bupivacaine<br>* bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative pethidine consumption | The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is > 3, pethidine 0.5 mg/kg. | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores | Face, Legs, Activity, Cry and Consolability (FLACC) scale will be used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain. FLACC scale will be measured at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours. | 24 hours postoperatively | 
| Time of first analgesia request. | Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia. | 24 hours postoperatively | 
| Incidence of adverse events | Complication related to the block or adverse events of the administered drugs. | 24 hours postoperatively |