Children ASA 1-2, aged 1 to 8 years. MedDRA version: 9.1 Level: LLT Classification code 10021945 Term: Infiltration anaesthesia
Conditions
Interventions
Trade Name: NAROPINA 2MG/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine
Concentration unit: % percent
Concentration type: equal
Concentration number: .2-
Trade Name:
Sponsors
ISTITUTO PER L`INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
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). 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: Children who have neurological, neuromuscular, psychiatric, convulsive or blood clotting disorders or any drug allergy will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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;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 w | — |
Countries
Italy
Outcome results
None listed