NCT04294537

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ospedale di Circolo - Fondazione Macchi · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Appendectomy
• Laparoscopy
• Anesthesia, Conduction
• Child, Preschool

Interventions

Type	Name	Description
PROCEDURE	TAP Block	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
PROCEDURE	LIA local infiltration	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.
PROCEDURE	General anesthesia	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.
DRUG	Postperative analgesia	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.

Timeline

• Start date: 2020-03-30
• Primary completion: 2020-04-30
• Completion: 2020-05-30
• First posted: 2020-03-04
• Last updated: 2020-03-04

Locations

1 site across 1 country: Italy