E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children ASA 1-2, aged 1 to 8 years. |
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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 | 10021945 |
E.1.2 | Term | Infiltration anaesthesia |
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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 |
The availability of new long-acting local anesthetics (ropivacaine and levobupivacaine), with lower toxicity, has increased the tumescent local anesthesia techniques in pediatric surgery. It has been found that wound infiltration with ropivacaine is an effective and simple method of relieving postoperative pain after inguinal hernia repair in children, but the effects of the infiltration with different concentrations of local anesthetic have never been compared in children. The aim of this study is to prove the effectiveness on postoperative pain of the surgical wound infiltration with ropivacaine using a concentration (0,1%) lower than the usual standard (0,2%). The use of lower concentrations could thus reduce the drug toxicity risks for the child. This study will analyze the effectiveness of local anesthetic wound infiltration with different concentrations of ropivacaine (0,2% vs 0,1%) in children after inguinal hernia repair under regional anesthesia. |
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E.2.2 | Secondary objectives of the trial |
The aim of the study is to evaluate postoperative analgesia, showing the efficacy of wound infiltration on pain control with lower local anesthetic concentration in order to decrease the risk of local anesthetic toxicity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Randomized, double-blind, placebo-controlled study. 90 children, ASA 1-2, aged 1 to 8 years, undergoing inguinal hernia repair under spinal anesthesia and light general anesthesia will be placed into 3 groups. The randomization will be organized at a central level (Epidemiology and Biostatistics Service, IRCCS Burlo Garofolo, Trieste) using a computer-generated list. An adequate hidden of the generated sequences will be guaranteed by the use of sealed, opaque and consecutively numbered envelopes containing the description of the therapy assigned by the randomization process. The envelopes will be opened by nurses who will prepare the syringes containing the drug at different dilutions. In this way the patient and the operator who will apply wound infiltration and the trained postoperative pain evaluator will be blind in respect to the solution administered. The results will be collected using a specific form and subsequently collected and processed at a central level (Epidemiology and Biostatistics Service, IRCCS Burlo Garofolo, Trieste). |
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E.4 | Principal exclusion criteria |
Children who have neurological, neuromuscular, psychiatric, convulsive or blood clotting disorders or any drug allergy will be excluded from the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The children will be randomized to receive at the end of surgery an infiltration of the surgical wound with 0.2% ropivacaine (standard treatment presently in use) (2ml/cm), or 0.1% ropivacaine (experimental treatment) (2 ml/cm). All the children will be undergo inguinal surgery under spinal anesthesia with hyperbaric bupivacaine 0.5% (0.2 mg/kg) and light general anesthesia with propofol (1-2 mg/kg) and L-ketamine (1 mg/kg). A premedication with oral midazolam (0.5 mg/kg) will be given 30 before surgery. Aim of this study is to evaluate the efficacy of postincisional wound infiltration with different concentrations of ropivacaine on postoperative pain in children during the 24 hours following surgery. Postoperative evaluation will be done both by medical and nursing staff using CHEOPS scale: every 15 minutes in the recovery room, every hour in the ward and then at home by trained parents. Pain assessment is different at different pediatric ages. For preschoolers rating scales are used to measure pain in response to behavioral parameters as crying, patient position, face expression and on biological measures as heart rate, blood pressure, respiratory rate and sweating. It is the observer who watches the children and assigns an appropriate pain score and subsequently decides the treatment. The Childrens Hospital of Eastern Ontario Pain Scale (CHEOPS) is a widely-used behavioral rating scale for preschoolers and older children (McGrath PA, et al. The Childrens Hospital of Eastern Ontario Pain Scale (CHEOPS). Advances in Pain Research and Therapy 1985; 9: 395-402). Rectal paracetamol (20 mg/kg/dose) will be administered when CHEOPS scale score >7, recording the number of doses/day, the administration number and the administration times. The parents of the children will be contacted by phone the day following discharge. |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |