Anesthesia, Conduction, Appendectomy, Child, Preschool, Laparoscopy
Conditions
Keywords
TAP Block, Wound Infiltration, Laparoscopic Appendectomy, Levobupivacaine, Pediatric Surgery, Pediatric Anesthesia
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.
Interventions
PROCEDURETAP 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
PROCEDURELIA 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.
PROCEDUREGeneral 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.
DRUGPostperative 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.
Sponsors
Ospedale di Circolo - Fondazione Macchi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed