Children aged over 1 year, undergoing elective abdominal laparoscopic surgery. MedDRA version: 9.1 Level: LLT Classification code 10023693 Term: Laparoscopy
Conditions
Interventions
Product Name: Ropivacaine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enlisting of 60 children aged over 1 year, undergoing elective abdominal laparoscopic surgery, is planned. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluding parameters will be: conversion from laparoscopy to open approach, diagnostic laparoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and efficacy of continuous peritoneal infusion of local anesthetics (ropivacaine)in children. To date it is unknown whether the technique is reliable, safe and which is the optimal dosage of the local anesthetic administered. The choice of extended use of continuous peritoneal infusion of ropivacaine also in the child, where postoperative pain relief is necessary, avoiding opioid side effects, is wished.;Secondary Objective: Evaluate postoperative analgesia, showing the efficacy and the safety of continuous peritoneal infusion of ropivacaine, in children after laparoscopic abdominal surgery. This study will evaluate the efficacy and the safety of the dosage of ropivacaine administered, the incidence of postoperative complications (respiratory depression, PONV, infections), the time to bowel transit recovery, the blood absorption of intraperitoneally instillated ropivacaine and the signs or symptoms of local anesthetic toxicity.;Primary end point(s): Aim of this study is to evaluate postoperative pain in children during the 24 hours following surgery. Postoperative evaluation will be done both by medical and nursing staff using CHEOPS scale after 1, 2, 3, 4, 8, 16 and 24 hours after surgery. Pain assessment is different at different pediatric ages. Opioids dosage administered will be evaluated too. | — |
Countries
Italy
Outcome results
None listed