Comparison between wound infiltration with different ropivacaine concentrations following inguinal herniotomy for postoperative analgesia in children: a randomized, double-blind, placebo-controlled study. - Wound infiltration with different ropivacaine concentrations in children

ISTITUTO PER L`INFANZIA BURLO GAROFOLO0 个研究点开始时间: 2008年12月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•Children who have neurological, neuromuscular, psychiatric, convulsive or blood clotting disorders or any drug allergy will be excluded from the study.

发起方

ISTITUTO PER L`INFANZIA BURLO GAROFOLO