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UnknownNCT04947072

Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREErector Spinae Plane BlockThe 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 anesthesiaPatient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5

Timeline

Start date
2020-09-14
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2021-07-01
Last updated
2021-12-29

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT04947072. Inclusion in this directory is not an endorsement.