Surgical Pleth Index- Relevance in Small Children

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Levobupivacaine; Drug: Saline

• Registration Number: NCT02045810
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-27
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Saline	Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.
Control group	Saline	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	Levobupivacaine	Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.
Control group	Levobupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Surgical Pleth Index (SPI) at the time of start of surgery	intraoperative

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland