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When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.
This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block | Active Comparator | Transverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side. The patient receives usual analgesia protocol. |
|
| local infiltration of the trocar wounds | Active Comparator | local infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening. The patient receives usual analgesia protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine Hydrochloride 2.5 MG/ML | Drug | To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative dose of nalbuphine in the 24 first hours post surgery | recording in mg/kg | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative dose of nalbuphine H0-H12 post surgery | recording in mg/kg | from beginning to 12th hour |
| cumulative dose of nalbuphine H13-H24 post surgery | recording in mg/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besancon | Besançon | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41777031 | Derived | Bloy G, Jurine A, Pili-Floury S, Auber F, Hild O, Guinot PG, Bouhemad B, Francois M, Vettoretti L, Bronnert R, Nguyen M, Chaussy Y, Besch G. Clinical effectiveness of transversus abdominis plane block versus local anaesthesia wound infiltration for postoperative pain relief after laparoscopic appendicectomy in children: A multicentre, double-blind, randomised, controlled phase III trial. Eur J Anaesthesiol. 2026 Mar 4. doi: 10.1097/EJA.0000000000002367. Online ahead of print. |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| From 13th hour to 24th hour |
| FLACC analgesia score at H1 H2 H6 H12 H24 | Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 | FLACC score will be performed from awakenig to 24 hours post surgery |
| FLACC score mean | Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 | FLACC score will be performed from awakenig to 24 hours surgery |
| individual variations of FLACC score | Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10 | FLACC score will be performed from awakenig to 24 hours surgery |
| timing of first injection of nalbuphine | recording date and time of first injection | in the first 24 post operative hours |
| incidence of post operative nausea and vomiting | recording the incidence post operative nausea and vomiting | in the first 24 post operative hours |
| timing of first standing up | recording date and time of first standing up | in the first 24 post operative hours |
| adverse events | adverse event monitoring | in the first 24 post operative hours |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |