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Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

Not Applicable
Conditions
Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery
Interventions
Procedure: Erector Spinae Plane Block
Procedure: Spinal anesthesia
Registration Number
NCT04947072
Lead Sponsor
Indonesia University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Spinal AnesthesiaSpinal anesthesiaPatient will receive spinal anesthesia at the level of L3-L4 or L4-L5
Spinal AnesthesiaErector Spinae Plane BlockPatient will receive spinal anesthesia at the level of L3-L4 or L4-L5
Erector Spinae Plane BlockErector Spinae Plane BlockPatient will receive single-shot ultrasound-guided erector spinae plane block at the level of T9 on the side which will be operated on.
Erector Spinae Plane BlockSpinal anesthesiaPatient will receive single-shot ultrasound-guided erector spinae plane block at the level of T9 on the side which will be operated on.
Primary Outcome Measures
NameTimeMethod
Incidence conversion to general anesthesiaintraoperatively

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 Outcome Measures
NameTimeMethod
Interleukin -6 plasma concentration24 hours after surgery

Interleukin 6 will be measured 3 times, before surgery, 6 hours after surgery and 24 hours after surgery.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital

🇮🇩

Jakarta Pusat, DKI Jakarta, Indonesia

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