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Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

Primary Purpose

Postoperative Pain, Nephrolithotomy, Percutaneous, Erector Spinae Plane Block

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae block
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing PNL between 18-65 years old

Exclusion Criteria:

  • serious cardiac, respiratory, hepatic, renal or haemotologic disease
  • mental disorder and hearing problem
  • anxiety, depression and / or other psychiatric disorders
  • pregnancy
  • refusal of patient
  • Allergy or contraindications to drugs used in the study
  • ASA > 2 Inflammation or infection over injection site Obese patients BMI ≥35/

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group 1:Conventional intravenous analgesia

Group 2:ESPB

Arm Description

Conventional intravenous analgesia applied according to surgeon's preference

A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used

Outcomes

Primary Outcome Measures

Visual Analog Scale
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Dynamic Visual Analog Scale
the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
Peak Expiratory Flow Rate( PEFR)
maximum speed of expiration as measured with a peak flow meter

Secondary Outcome Measures

Time for first analgesic requirement
Time between end of surgery and patients first analgesic demand
ambulation time
first postoperative mobilization time of the patient
length of hospital stay
day of hospitalization
Rikert Agitation Scale
postoperative agitation score unarousable very sedated sedated calm and cooperative agitated very agitated dangerous agitation
nausea and vomiting
incidence of nausea and vomiting
patient satisfaction with anesthesia and analgesia
4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
starting oral intake
first oral intake
urinary catheter releated pain score(Visual Analog Scale)
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
surgeon satisfaction with anesthesia and analgesia
4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)

Full Information

First Posted
June 28, 2020
Last Updated
July 15, 2020
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04474873
Brief Title
Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?
Official Title
SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

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
This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.
Detailed Description
Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL. Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nephrolithotomy, Percutaneous, Erector Spinae Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1:Conventional intravenous analgesia
Arm Type
No Intervention
Arm Description
Conventional intravenous analgesia applied according to surgeon's preference
Arm Title
Group 2:ESPB
Arm Type
Active Comparator
Arm Description
A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Time Frame
postoperative 24 hours
Title
Dynamic Visual Analog Scale
Description
the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
Time Frame
postoperative 24 hours
Title
Peak Expiratory Flow Rate( PEFR)
Description
maximum speed of expiration as measured with a peak flow meter
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Time for first analgesic requirement
Description
Time between end of surgery and patients first analgesic demand
Time Frame
24 hours
Title
ambulation time
Description
first postoperative mobilization time of the patient
Time Frame
5 days
Title
length of hospital stay
Description
day of hospitalization
Time Frame
1 week
Title
Rikert Agitation Scale
Description
postoperative agitation score unarousable very sedated sedated calm and cooperative agitated very agitated dangerous agitation
Time Frame
24 hours
Title
nausea and vomiting
Description
incidence of nausea and vomiting
Time Frame
24 hours
Title
patient satisfaction with anesthesia and analgesia
Description
4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
Time Frame
24 hour
Title
starting oral intake
Description
first oral intake
Time Frame
48 hours
Title
urinary catheter releated pain score(Visual Analog Scale)
Description
the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Time Frame
postoperative 24 hours
Title
surgeon satisfaction with anesthesia and analgesia
Description
4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing PNL between 18-65 years old Exclusion Criteria: serious cardiac, respiratory, hepatic, renal or haemotologic disease mental disorder and hearing problem anxiety, depression and / or other psychiatric disorders pregnancy refusal of patient Allergy or contraindications to drugs used in the study ASA > 2 Inflammation or infection over injection site Obese patients BMI ≥35/
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semih Baskan, 2
Organizational Affiliation
Ankara City Hospital Anesthesiology Department
Official's Role
Study Director
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31620856
Citation
Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.
Results Reference
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Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

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