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 childre

• Conditions: Children ASA 1-2, aged 1 to 8 years.; MedDRA version: 9.1Level: LLTClassification code 10021945Term: Infiltration anaesthesia

• Registration Number: EUCTR2008-007996-26-IT
• Lead Sponsor: ISTITUTO PER L`INFANZIA BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified