Clinical trial NCT04947072: Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery
Keywords: Erector Spinae Plane Block
Percutaneous Nephrolithotomy
Interleukin-6, Effectiveness
Tramadol patient controlled analgesia
Visual analog scale
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence conversion to general anesthesia
timeFrame: intraoperatively
Secondary outcomes:
measure: Interleukin -6 plasma concentration
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Pry P Pryambodho, Doctor
role: PRINCIPAL_INVESTIGATOR
References: