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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT05845281

Collaborator

(none)

Enrollment

Location

Arms

13.5

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis Percutaneous Analgesia PCA	Procedure: ESP, Erector Spina Plane Block	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The patients weredivided in two groups. Thirty patients were assigned to each group. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. Group ESP underwent an erector spina block after the surgical procedure. Intravenous patient-controlled analgesia with tramadol was applied to group PCA patients. VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, 1th, 3th, 6th and 12th hours after the operation.The patients weredivided in two groups. Thirty patients were assigned to each group. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. Group ESP underwent an erector spina block after the surgical procedure. Intravenous patient-controlled analgesia with tramadol was applied to group PCA patients. VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, 1th, 3th, 6th and 12th hours after the operation.

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Erector Spina Plane Block and Intravenous Patient-controlled Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Actual Study Start Date :

Feb 2, 2022

Actual Primary Completion Date :

Feb 2, 2023

Actual Study Completion Date :

Mar 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group ESP, Erector Spina Plane Block (n= 30) 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.	Procedure: ESP, Erector Spina Plane Block 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. Other Names: PCA, Patient Controlled Analgesia
Experimental: Group PCA, Patient Controlled Analgesia (n= 30) 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.	Procedure: ESP, Erector Spina Plane Block 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. Other Names: PCA, Patient Controlled Analgesia

Arm

Intervention/Treatment

Active Comparator: Group ESP, Erector Spina Plane Block (n= 30)

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.

Procedure: ESP, Erector Spina Plane Block

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.

Other Names:

PCA, Patient Controlled Analgesia

Experimental: Group PCA, Patient Controlled Analgesia (n= 30)

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.

Procedure: ESP, Erector Spina Plane Block

Other Names:

PCA, Patient Controlled Analgesia

Outcome Measures

Primary Outcome Measures

Post operative analgesia [24 hours]
Visual Analog Scale score were recorded at the post operative 30 minutes, 1st, 3rd, 6th and 12th hours after the operation. High VAS score was interpreted as severe pain in patients. When the VAS score was 4 and above, additional analgesic (15 mg/kg paracetamol) was given intravenously.
Additional analgesic drug [24 hours]
When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams.
Patient satisfaction [24 hours]
Patient satisfaction was recorded using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours after the operation. Patient satisfaction was scored between 1 and 5 using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours postoperatively. 1 point not satisfied at all, 2 points dissatisfied, 3 points not sure, 4 points satisfied, 5 points very satisfied.
First walking time after surgery [24 hours]
Mobilization status was checked and recorded at the 30th minute, 1st, 3rd, 6th and 12th hours after the surgery. We accepted the extubation time as the postoperative 0th hour. We determined the time when the patients started walking for the first time after the surgery accordingly.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yüzüncü Yıl University, Faculty of Medicine	Van	Tusba	Turkey	65080

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

Principal Investigator: Hacı Yusuf YG Güneş, Assist.prof, Van Yüzüncü Yıl University Van, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hacı Yusuf Güneş, MD, Assistant proffesor, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT05845281

Other Study ID Numbers:

2022-03-03

First Posted:

May 6, 2023

Last Update Posted:

May 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hacı Yusuf Güneş, MD, Assistant proffesor, Yuzuncu Yıl University

Percutaneous

Nephrolithotomy

Plane Block

Patient-controlled analgesia

Additional relevant MeSH terms:

Nephrolithiasis

Kidney Calculi

Study Results

No Results Posted as of May 8, 2023