TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: a Pilot Study

Study Overview
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Brief Summary
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Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children

Detailed Description
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Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children. The available local anesthesia techniques include wound infiltration or wall blocks such as the TAP (transversus abdominis plane) block. The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time. The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.

Official Title
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TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study

Conditions
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Appendectomy, Laparoscopy, Anesthesia, Conduction, Child, Preschool

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: LIA local infiltration
* Procedure: General anesthesia
* Drug: Postperative analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 3 and 16 years, candidates for laparoscopic appendectomy for suspected acute appendicitis. ASA physical status Class I and II Informed consent signed by parents / legal guardians Exclusion Criteria: severe obesity (BMI> 95th percentile for age and weight) perforated appendicitis paralytic ileum non-stabilized neuropathies allergy to local anesthetics or analgesics used in the study protocol. patients on chronic opiate treatment need for perioperative hospitalization in intensive care with sedation and / or mechanical ventilation

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block<br>Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side. | Procedure: TAP Block<br>* At the end of surgery patients will receive bilateral ultrasound-guided single-shot TAP block: 0,15% levobupivacaine 0,75 mg/kg per side will be injected between internal oblique and transveralis fascia<br>Procedure: General anesthesia<br>* General anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1). 30 minutes after induction will be administered paracetamol 15 mg/kg iv.<br>Drug: Postperative analgesia<br>* During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery. In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.<br>|
| Active Comparator: LIA - local wound infiltration<br>Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg | Procedure: LIA local infiltration<br>* At the end of surgery 0,5% levobupivacaine 1.5 mg/kg, equally distributed between ports, injected in the skin and subcutaneous tissue during wound closure.<br>Procedure: General anesthesia<br>* General anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1). 30 minutes after induction will be administered paracetamol 15 mg/kg iv.<br>Drug: Postperative analgesia<br>* During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery. In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at 2 hours | Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 2 hours after the end of the surgery. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at 4-12-24 hours | Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 4 hours, 12 hours and 24 hours from the end of the surgery. | from 4 to 24 postoperative hours | 
| Total opioid consumption | Differences in tramadol rescue use (expressed in mg/kg) in the TAP group compared to the LIA group | from 2 to 24 postoperative hours | 
| time to first opioid analgesic rescue | Differences in the elapsed time before first request for tramadol rescue in the TAP group compared to the LIA group | from 2 to 24 postoperative hours | 
| Side effects | Differences in the incidence of side effects depending on the anesthetic technique adopted | from 2 to 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP Block, Wound Infiltration, Laparoscopic Appendectomy, Levobupivacaine, Pediatric Surgery, Pediatric Anesthesia