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

Primary Purpose

Nephrolithiasis, Percutaneous, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivakain + deksametazon Adjuvant
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Percutaneous, Nephrolithotomy, Plane Block, Patient-controlled analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Haci Yusuf GUNES

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

Group PCA, Patient Controlled Analgesia (n= 30)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Post operative analgesia
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
October 6, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05845281
Brief Title
Comparison of Erector Spinae Plane Block and Intravenous Patient-controlled Analgesia in Percutaneous Nephrolithotomy
Official Title
Comparison of Erector Spina Plane Block and Intravenous Patient-controlled Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Percutaneous, Analgesia, PCA
Keywords
Percutaneous, Nephrolithotomy, Plane Block, Patient-controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ESP, Erector Spina Plane Block (n= 30)
Arm Type
Active Comparator
Arm 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.
Arm Title
Group PCA, Patient Controlled Analgesia (n= 30)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Bupivakain + deksametazon Adjuvant
Other Intervention Name(s)
PCA, Patient Controlled Analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operative analgesia
Description
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.
Time Frame
24 hours
Title
Additional analgesic drug
Description
When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams.
Time Frame
24 hours
Title
Patient satisfaction
Description
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.
Time Frame
24 hours
Title
First walking time after surgery
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hacı Yusuf YG Güneş, Assist.prof
Organizational Affiliation
Van Yüzüncü Yıl University Van, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haci Yusuf GUNES
City
VAN
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and statistical analysis plan will be share for other resarchers.
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
The access can be provided via the e-mail addresses below hyusufgunes@hotmail.com
Citations:
PubMed Identifier
33470685
Citation
Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854.
Results Reference
background
PubMed Identifier
32994063
Citation
Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan;79(1):114-121. doi: 10.1016/j.eururo.2020.09.026. Epub 2020 Sep 29.
Results Reference
background
PubMed Identifier
33632189
Citation
Deng W, Hou XM, Zhou XY, Zhou QH. Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial. BMC Pulm Med. 2021 Feb 25;21(1):68. doi: 10.1186/s12890-021-01432-7.
Results Reference
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Comparison of Erector Spinae Plane Block and Intravenous Patient-controlled Analgesia in Percutaneous Nephrolithotomy

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