AnesthesiaSPIinChildrenNCT02045810
Surgical Pleth Index- Relevance in Small Children
A study testing Levobupivacaine and Saline in people with Anesthesia, run by Tampere University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Levobupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 0-2 years
- Elective surgery planned for inguinal hernia, or testicle retention
- Written informed consent from parent received
- ASA I-III
Who cannot join
- Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study
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
- Anesthesia
- Being tested
- Levobupivacaine, Saline
- Keywords
- Measurement, nosiseption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Levobupivacaine; Drug: 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. Receives: Drug: Levobupivacaine; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Pleth Index (SPI) at the time of start of surgery
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jarkko Harju, MD, Principal investigator, Tampere University HospitalArvi Yli-Hankala, Prof, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045810
- Sponsor's protocol ID
- JH2013-2
- Other IDs
- 2013-003607-19
- Acronym
- SPIinChildren
- Status last verified
- Mar 2015
- First submitted
- 22 Jan 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study
- ClinicalTrials.gov ID
- NCT02045810
- Acronym / sponsor ID
- SPIinChildren / JH2013-2
- Conditions
- Anesthesia
- Keywords
- Measurement, nosiseption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Levobupivacaine, Drug: SalinePatients 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 | Placebo comparator | Drug: Levobupivacaine, Drug: SalinePatients 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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age 0-2 years
- Elective surgery planned for inguinal hernia, or testicle retention
- Written informed consent from parent received
- ASA I-III
Key exclusion criteria (1 listed)
- Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levobupivacaine | Drug | Control group, Treatment |
| Saline | Drug | Control group, Treatment |
Primary outcome
Surgical Pleth Index (SPI) at the time of start of surgery
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 27543530Harju 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarkko Harju, MD principal investigator
Tampere University Hospital
Arvi Yli-Hankala, Prof, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine and Saline in people with Anesthesia, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Pleth Index (SPI) at the time of start of surgery (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.