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

O

Ospedale di Circolo - Fondazione Macchi

Status

Unknown

Conditions

Anesthesia, Conduction
Laparoscopy
Child, Preschool
Appendectomy

Treatments

Procedure: LIA local infiltration
Procedure: General anesthesia
Drug: Postperative analgesia
Procedure: TAP Block

Study type

Interventional

Funder types

Other

Identifiers

NCT04294537
VARPON001

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

TAP block
Experimental group
Description:
Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
Treatment:
Procedure: TAP Block
Procedure: General anesthesia
Drug: Postperative analgesia
LIA - local wound infiltration
Active Comparator group
Description:
Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
Treatment:
Procedure: General anesthesia
Drug: Postperative analgesia
Procedure: LIA local infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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