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

NCT04294537 — Not applicable, Unknown, 20 participants, Ospedale di Circolo - Fondazione Macchi

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

RegistryNCT04294537
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment20 (Estimated)
SponsorOspedale di Circolo - Fondazione Macchi (Other)
ConditionsAppendectomy, Laparoscopy, Anesthesia, Conduction, Child, Preschool
InterventionsTAP Block, LIA local infiltration, General anesthesia, Postperative analgesia (Procedure, drug)
Datesstart 2020-03-30 (estimated), primary completion 2020-04-30 (estimated), completion 2020-05-30 (estimated), first posted 2020-03-04, last updated 2020-03-04
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Appendectomy All trials for Laparoscopy All trials of TAP Block All trials of LIA local infiltration

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TAP blockExperimentalProcedure: TAP Block; Procedure: General anesthesia; Drug: Postperative analgesiaBilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
LIA - local wound infiltrationActive comparatorProcedure: LIA local infiltration; Procedure: General anesthesia; Drug: Postperative analgesiaWound infiltration with 0,5% levobupivacaine 1.5 mg/kg
  • TAP Block (Procedure): 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
  • LIA local infiltration (Procedure): 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.
  • General anesthesia (Procedure): 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.
  • Postperative analgesia (Drug): 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.

+Outcome measures

Primary outcomes

  • Postoperative pain at 2 hours [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.

Secondary outcomes

  • Postoperative pain at 4-12-24 hours [from 4 to 24 postoperative 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.
  • Total opioid consumption [from 2 to 24 postoperative hours]: Differences in tramadol rescue use (expressed in mg/kg) in the TAP group compared to the LIA group
  • time to first opioid analgesic rescue [from 2 to 24 postoperative hours]: Differences in the elapsed time before first request for tramadol rescue in the TAP group compared to the LIA group
  • Side effects [from 2 to 24 postoperative hours]: Differences in the incidence of side effects depending on the anesthetic technique adopted

+Eligibility

Sex: All, ages: 3 Years to 16 Years

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

+Locations (1)

FacilityCityCountryStatus
Department of Day Surgery Ospedale di Circolo VareseVarese, VAItaly