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

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

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

Study Overview

• Status: Unknown
• Conditions: Laparoscopy; Appendectomy; Child, Preschool; Anesthesia, Conduction
• Intervention / Treatment: Procedure: TAP Block; Procedure: General anesthesia; Drug: Postperative analgesia; Procedure: LIA local infiltration

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • VA
    • Varese, VA, Italy, 21100
      • Department of Day Surgery Ospedale di Circolo Varese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block; Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.	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: 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.
Active Comparator: LIA - local wound infiltration; Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain at 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.	2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ospedale di Circolo - Fondazione Macchi

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2020
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: March 1, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Levobupivacaine; Laparoscopic Appendectomy; Wound Infiltration; Pediatric Surgery; TAP Block; Pediatric Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: VARPON001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No