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Clinical Trials/EUCTR2008-007996-26-IT
EUCTR2008-007996-26-IT
Active, not recruiting
Not Applicable

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 sitesDecember 17, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children ASA 1-2, aged 1 to 8 years.
Sponsor
ISTITUTO PER L`INFANZIA BURLO GAROFOLO
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ISTITUTO PER L`INFANZIA BURLO GAROFOLO

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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