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

NCT04294537 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-03-04

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Ospedale di Circolo - Fondazione Macchi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-04-30
Completion
2020-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294537 on ClinicalTrials.gov