Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index

Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: TRADITIONAL EPIDURAL; Procedure: DURAL PUNCTURE EPIDURAL

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşenur Dostbil; Phone Number: +905333677796; Email: adostbil@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TRADITIONAL EPIDURAL; standard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia	Procedure: TRADITIONAL 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)
Active Comparator: DURAL 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)	Procedure: DURAL 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of local aneshesics	to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time interval and SPI value dropping	defining time interval between LA administration and SPI value dropping under 50 and hemodynamy	intraoperative
local anesthesic consumption	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)	during the procedure/surgery and during 30 minutes of PACU stay

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Director: Aysenur Dostbil, Ataturk University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: B.30.2.ATA.0.01.00/576

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No