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Clinical Trials/NCT04947072
NCT04947072
Unknown
Not Applicable

Comparison Between Erector Spinae Plane Block and Spinal as Surgical Anesthesia and Analgesia in Percutaneous Nephrolithotomy Patient : Conversion to General Anesthesia, Interleukin-6, Postoperative Pain and Opioid Consumption

Indonesia University1 site in 1 country30 target enrollmentSeptember 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery
Sponsor
Indonesia University
Enrollment
30
Locations
1
Primary Endpoint
Incidence conversion to general anesthesia
Last Updated
4 years ago

Overview

Brief Summary

This study aimed to compare the Effectiveness of Erector Spinae plane block to Spinal as a surgical anesthesia and analgesia in Percutaneous Nephrolithotomy patient

Detailed Description

Thirty subjects (who meet all inclusion criteria and do not have exclusion criteria) are given informed consent before enrolling the study and randomized into two groups: erector spinae plane block and spinal. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry will be set on the subjects in the operation room. Peripheral venous blood samples will be taken for IL-6 examination. All patients will be sedated using Target Controlled Infusion with propofol (Schnider model, effect site) to obtain mild-moderate sedation prior to the block. On Erector Spinae Plane group, single-shot ultrasound guided block will be performed on the operated side with stimuplex 100 mm needle and 25 ml of isobaric bupivacaine 0.5% with epinephrine 1:200.000 will be administered at level Th 9. On the Spinal group, spinal anesthesia will be performed on lateral decubitus position at the level of L3-L4 or L4-L5 and hyperbaric bupivacaine 0.5% 16-18 mg will be given as regimen. Prior to urethral manipulation, all subjects will be given fentanyl iv 50 mcg and sedation with TCI Propofol will be maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping with a scalpel at the level of the incision before the surgery. The ESP block was considered successful in providing surgical anaesthesia when there was no movement and significant changes in vital signs during skin clamping and throughout the surgery.

Registry
clinicaltrials.gov
Start Date
September 14, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pryambodho Pryambodho

Doctor

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Age 18 years old and above
  • ASA 1,2 and 3
  • Patient who will undergo elective supine Percutaneous Nephrolithotomy

Exclusion Criteria

  • Patient who does not agree to be included in the study
  • BMI \<18.5 kg/m2 or \> 40 kg/m2
  • Patient with single functional kidney
  • Patient who is contraindicated for local anesthetics
  • Patient who has severe heart disorder
  • Patient with communication disability and cognitive disorders
  • Patient with chronic pain with history of high opioid consumption and or alcohol addiction
  • Pregnant patient

Outcomes

Primary Outcomes

Incidence conversion to general anesthesia

Time Frame: intraoperatively

This outcome will be measured based on the concentration of propofol needed throughout the surgery. If the concentration of propofol exceeds 3.5 mcg/ml, anesthesia will be converted to a general anesthesia.

Secondary Outcomes

  • Interleukin -6 plasma concentration(24 hours after surgery)

Study Sites (1)

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