E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children aged over 1 year, undergoing elective abdominal laparoscopic surgery. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023693 |
E.1.2 | Term | Laparoscopy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Enlisting of 60 children aged over 1 year, undergoing elective abdominal laparoscopic surgery, is planned. |
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E.4 | Principal exclusion criteria |
Excluding parameters will be: conversion from laparoscopy to open approach, diagnostic laparoscopy. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |