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

Not Applicable

• Conditions: Appendectomy; Laparoscopy; Anesthesia, Conduction; Child, Preschool
• Interventions: Procedure: TAP Block; Procedure: LIA local infiltration; Procedure: General anesthesia; Drug: Postperative analgesia

• Registration Number: NCT04294537
• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-09
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-01
• Last Update Submitted: 2020-03-01
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Study Start: 2020-03-30
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block	TAP Block	Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
TAP block	General anesthesia	Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
TAP block	Postperative analgesia	Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
LIA - local wound infiltration	LIA local infiltration	Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
LIA - local wound infiltration	General anesthesia	Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
LIA - local wound infiltration	Postperative analgesia	Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Department of Day Surgery Ospedale di Circolo Varese; 🇮🇹 Varese, VA, Italy