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Comparison of Erector Spinae Plane Block and Intravenous Patient-controlled Analgesia in Percutaneous Nephrolithotomy

Y

Yuzuncu Yıl University

Status

Completed

Conditions

Percutaneous
PCA
Analgesia
Nephrolithiasis

Treatments

Procedure: Bupivakain + deksametazon Adjuvant

Study type

Interventional

Funder types

Other

Identifiers

NCT05845281
02.03. 2022/04

Details and patient eligibility

About

The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.

Full description

ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study.

The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.

VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after the operation.

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists (ASA) class I-III,
  • Between 18-65 years old,
  • Percutaneous nephrolithotomy surgery,
  • Patients who agreed to participate in the study

Exclusion criteria

  • Obesity (BMI≥ 35)
  • Coagulopathy
  • Active Infection
  • Drug allergies
  • Pregnancy
  • 65 years and older

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Group ESP, Erector Spina Plane Block (n= 30)
Active Comparator group
Description:
After the surgical procedure was completed in patients who underwent general anesthesia, the necessary sterility was provided for the ESPB procedure while the patient was in the lateral position. 1mg/kg 0.5% bupivacaine + 1mg/kg 2% lidocaine was drawn into the same syringe and the volume was completed to 20 ml with normal saline. A linear 10-18 MHz USG probe was placed at the thoracic 7 level (Esaote MyLab 30, Geneva, Italy) in the paramedian plane between two transverse processes. The prepared local anesthetic drug was administered under the guidance of USG.
Treatment:
Procedure: Bupivakain + deksametazon Adjuvant
Group PCA, Patient Controlled Analgesia (n= 30)
Experimental group
Description:
For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.
Treatment:
Procedure: Bupivakain + deksametazon Adjuvant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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