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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04294537
• Other study ID #: VARPON001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: March 2020
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Conduction
• Appendectomy
• Child, Preschool
• Laparoscopy

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Department of Day Surgery Ospedale di Circolo Varese	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Side effects	Differences in the incidence of side effects depending on the anesthetic technique adopted	from 2 to 24 postoperative hours