Clinical trial

TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children

Name
2021/571
Description
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.
Trial arms
Trial start
2021-07-30
Estimated PCD
2023-12-25
Trial end
2024-05-25
Treatment
Levobupivacaine Hydrochloride 2.5 MG/ML
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
Arms:
TAP Block, local infiltration of the trocar wounds
Size
110
Primary endpoint
cumulative dose of nalbuphine in the 24 first hours post surgery
24 hours
Eligibility criteria
Inclusion Criteria: * Age betwween 3 and 15 years * Weight \< or = 50 kg * indicaction of coelioscopic appendicectomy * ASA 1,2 or 3 * consent of the children and the holder of parental autority Exclusion Criteria: * Age\<3 years or \> 15years or weight \> 50kg * refusal of the children and the holder of parental autority * ASA 4 * Peritonitis * Patients with long term morphinic traitment * Epilepsy * Hepato-cellular insuffisiancy * local anesthesia allergy or nalbuphine allergy * coagulation abnomrmality * exclusion of health insurance
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-03-30

1 organization

1 product

3 indications

Indication
Pediatrics
Indication
Analgesic