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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003607-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug |
| ||
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Pleth Index (SPI) at the time of start of surgery | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jarkko Harju, MD | Tampere University Hospital | Principal Investigator |
| Arvi Yli-Hankala, Prof, MD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543530 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |