NCT02045810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 22, 2014

Last Update Submit

March 13, 2015

Conditions

Anesthesia

Keywords

Measurementnosiseption

Outcome Measures

Primary Outcomes (1)

  • Surgical Pleth Index (SPI) at the time of start of surgery

    intraoperative

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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: LevobupivacaineDrug: Saline

Control group

PLACEBO COMPARATOR

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: LevobupivacaineDrug: Saline

Interventions

LevobupivacaineDRUG
Control groupTreatment
SalineDRUG
Control groupTreatment

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27543530DERIVED

MeSH Terms

Interventions

LevobupivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jarkko Harju, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Arvi Yli-Hankala, Prof, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

FI(1)