NCT04294537

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

November 9, 2019

Last Update Submit

March 1, 2020

Conditions

AppendectomyLaparoscopyAnesthesia, ConductionChild, Preschool

Keywords

TAP BlockWound InfiltrationLaparoscopic AppendectomyLevobupivacainePediatric SurgeryPediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Postoperative pain at 4-12-24 hours

    from 4 to 24 postoperative hours

  • Total opioid consumption

    from 2 to 24 postoperative hours

  • time to first opioid analgesic rescue

    from 2 to 24 postoperative hours

  • Side effects

    from 2 to 24 postoperative hours

Study Arms (2)

TAP block

EXPERIMENTAL

Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.

Procedure: TAP BlockProcedure: General anesthesiaDrug: Postperative analgesia

LIA - local wound infiltration

ACTIVE COMPARATOR

Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg

Procedure: LIA local infiltrationProcedure: General anesthesiaDrug: Postperative analgesia

Interventions

TAP BlockPROCEDURE

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

TAP block
LIA local infiltrationPROCEDURE

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.

LIA - local wound infiltration
General anesthesiaPROCEDURE

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.

LIA - local wound infiltrationTAP block
Postperative analgesiaDRUG

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.

LIA - local wound infiltrationTAP block

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte

Study Record Dates

First Submitted

November 9, 2019

First Posted

March 4, 2020

Study Start

March 30, 2020

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

IT(1)