Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery
Conditions
Keywords
Erector Spinae Plane Block, Percutaneous Nephrolithotomy, Interleukin-6, Effectiveness, Tramadol patient controlled analgesia, Visual analog scale
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.
Interventions
PROCEDUREErector Spinae Plane Block
The block will be performed at the level of T9 on the site that will be operated and patient will be given Bupivacaine isobaric 0.5% 25 ml with epinephrine 1:200.000
PROCEDURESpinal anesthesia
Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence conversion to general anesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Interleukin -6 plasma concentration | 24 hours after surgery | Interleukin 6 will be measured 3 times, before surgery, 6 hours after surgery and 24 hours after surgery. |
Countries
Indonesia
Contacts
Primary ContactPry P Pryambodho, doctor
Backup ContactAida Rosita R Tantri
Outcome results
None listed