Surgical Pleth Index- Relevance in Small Children (SPIinChildren)

Tampere University Hospital

Status: Completed

Conditions: Anesthesia

Treatments: Drug: Levobupivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02045810

JH2013-2

2013-003607-19 (EudraCT Number)

Details and patient eligibility

About

Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.

Enrollment: 30 patients

Sex: All

Ages: Under 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 0-2 years
• Elective surgery planned for inguinal hernia, or testicle retention
• Written informed consent from parent received
• ASA I-III

Exclusion criteria

• Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.

Treatment:

Drug: Levobupivacaine

Drug: Saline

Control group

Placebo Comparator group

Description:

Patients receive a plasebo saline injetion at the site of ileoinguinal block prior to surgery and an injectio with local anesthetics after surgery. The treatment group is blinded for caregiver.

Treatment:

Drug: Levobupivacaine

Drug: Saline