CompletedNCT02045810SPIinChildrenUpdated Mar 17, 2015

Surgical Pleth Index- Relevance in Small Children

An interventional study of Levobupivacaine and Saline in Anesthesia, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged Up to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by Tampere University Hospital · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: Up to 2 Years
Sex: All

Study 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.

Conditions studied

Anesthesia

Keywords

Measurement
nosiseption

In context

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 2 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 30 participants (actual)

Study arms

Active comparator
Treatment
Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.
Drug: Levobupivacaine · Drug: Saline
Placebo comparator
Control group
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.
Drug: Levobupivacaine · Drug: Saline

Interventions

DrugLevobupivacaine
DrugSaline

What researchers measure

Primary outcomes

Surgical Pleth Index (SPI) at the time of start of surgery
Time frame: intraoperative

Study locations

1 site

Tampere University Hospital
Tampere, 33521, Finland

References and documents

Publications

Harju J, Kalliomaki ML, Leppikangas H, Kiviharju M, Yli-Hankala A. Surgical pleth index in children younger than 24 months of age: a randomized double-blinded trial. Br J Anaesth. 2016 Sep;117(3):358-64. doi: 10.1093/bja/aew215. PubMed 27543530 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02045810
Lead sponsor: Tampere University Hospital
Responsible party: Sponsor
First posted: Jan 27, 2014
Start date: Jan 2014
Primary completion: Mar 2015
Completion: Mar 2015
Last update: Mar 17, 2015

Study contacts

Jarkko Harju, MD

principal investigator · Tampere University Hospital

Arvi Yli-Hankala, Prof, MD

principal investigator · Tampere University Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Tampere University Hospital

Start the discussion