TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study
| Registry | NCT04294537 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Ospedale di Circolo - Fondazione Macchi (Other) |
| Conditions | Appendectomy, Laparoscopy, Anesthesia, Conduction, Child, Preschool |
| Interventions | TAP Block, LIA local infiltration, General anesthesia, Postperative analgesia (Procedure, drug) |
| Dates | start 2020-03-30 (estimated), primary completion 2020-04-30 (estimated), completion 2020-05-30 (estimated), first posted 2020-03-04, last updated 2020-03-04 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Appendectomy All trials for Laparoscopy All trials of TAP Block All trials of LIA local infiltration
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TAP block | Experimental | Procedure: TAP Block; Procedure: General anesthesia; Drug: Postperative analgesia | Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side. |
| LIA - local wound infiltration | Active comparator | Procedure: LIA local infiltration; Procedure: General anesthesia; Drug: Postperative analgesia | Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg |
Sex: All, ages: 3 Years to 16 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Day Surgery Ospedale di Circolo Varese | Varese, VA | Italy |