Analgesia
Conditions
Brief summary
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI\>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
Interventions
PROCEDURETRADITIONAL EPIDURAL
epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)
PROCEDUREDURAL PUNCTURE EPIDURAL
group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 18-60 * ASA I-III * grade I unilateral PNL
Exclusion criteria
* BMI \> 40 kg/m2 * drug or alcohol abuse history in the last 6 mounts * chronic opoid usage or had chronic pain longer than 6 weeks * peripheral and central neurological disorders * preoperative hemodynamic disorders * irregular sinus rhythm and pace makers * diabetes, severe lung and major liver diseases with increasing biluribin * use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days * who are pregnant and breast feeding * not willing to participate * allergic or intolerant to any of the drugs in the study * procedures that take less than 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| consumption of local aneshesics | intraoperative | to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time interval and SPI value dropping | intraoperative | defining time interval between LA administration and SPI value dropping under 50 and hemodynamy |
| local anesthesic consumption | during the procedure/surgery and during 30 minutes of PACU stay | total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI\>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis) |
Contacts
Primary ContactAyşenur Dostbil
Outcome results
None listed