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Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

Primary Purpose

Nephrolithotomy, Percutaneous, Anesthetics, Local, Nerve Block

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound Guided Erector Spinae Plane Block Catheterisation
Bupivacaine 0.25% Injectable Solution
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithotomy, Percutaneous focused on measuring Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
  • Patients who has informed consent for study
  • Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II

Exclusion Criteria:

  • Patient's refusal to participate
  • Patients under 18 years of age
  • Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
  • Patients with known local anesthetic allergy
  • Patients with Body mass index > 35
  • Patients diagnosed sepsis and bacteriemia,
  • Skin infection at the injection site,
  • Patients with previous spinal surgery
  • History of coagulopathy or anticoagulant therapy
  • Patients with uncontrolled diabetes ,
  • Uncoordinated patients,
  • Psychological and emotional lability,
  • Surgical intervention longer than 3 hours.

Sites / Locations

  • Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

GCont

GBlock

Arm Description

Only dressing will be applied to patients without actually nerve catheter performed

Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially. 20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2 *10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.

Outcomes

Primary Outcome Measures

Dosage of Drugs
Amounts of drugs per kilogram per hour will be recorded
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded during the first steps as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded during the procedure as reported by the patient according to NRS

Secondary Outcome Measures

Opioid Consumption
Opioids(Tramadol) will be administered to patients in case demanded.
Discharge
Day of the discharge

Full Information

First Posted
August 28, 2018
Last Updated
April 21, 2021
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03652103
Brief Title
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
Official Title
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
March 10, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL). One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL. The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.
Detailed Description
Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well. To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia. The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking. Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithotomy, Percutaneous, Anesthetics, Local, Nerve Block, Erector Spinae Plane Block, Pain, Postoperative, Anesthesia and Analgesia
Keywords
Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two groups involved. First group will receive total intravenous anesthesia and erector spinae plane block catheter Second group will receive total intravenous anesthesia and routine analgesia protocol for percutaneous Nephrolithotomy procedures.
Masking
Care Provider
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCont
Arm Type
No Intervention
Arm Description
Only dressing will be applied to patients without actually nerve catheter performed
Arm Title
GBlock
Arm Type
Experimental
Arm Description
Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially. 20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2 *10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Erector Spinae Plane Block Catheterisation
Intervention Description
After receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
Marcain
Intervention Description
Perineural Injection
Primary Outcome Measure Information:
Title
Dosage of Drugs
Description
Amounts of drugs per kilogram per hour will be recorded
Time Frame
During procedure
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
30th minute postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
60th minute postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
2nd hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
6th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
12th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
24th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
48th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded during the first steps as reported by the patient according to NRS
Time Frame
Mobilisation at postoperative day (POD) 1
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded during the procedure as reported by the patient according to NRS
Time Frame
At the time of removal of nephrostomy at postoperative day (POD) 2
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Opioids(Tramadol) will be administered to patients in case demanded.
Time Frame
48 hour post-operatively
Title
Discharge
Description
Day of the discharge
Time Frame
240 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia Patients who has informed consent for study Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II Exclusion Criteria: Patient's refusal to participate Patients under 18 years of age Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.) Patients with known local anesthetic allergy Patients with Body mass index > 35 Patients diagnosed sepsis and bacteriemia, Skin infection at the injection site, Patients with previous spinal surgery History of coagulopathy or anticoagulant therapy Patients with uncontrolled diabetes , Uncoordinated patients, Psychological and emotional lability, Surgical intervention longer than 3 hours.
Facility Information:
Facility Name
Izmir Bozyaka Training and Research Hospital
City
Karabaglar
State/Province
İzmir
ZIP/Postal Code
35170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

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