Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?

This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Erector Spinae Plane Block; Nephrolithotomy, Percutaneous
• Intervention / Treatment: Procedure: erector spinae block

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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/

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1:Conventional intravenous analgesia; Conventional intravenous analgesia applied according to surgeon's preference
Active Comparator: Group 2:ESPB; 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	Procedure: erector spinae block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	postoperative 24 hours
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	postoperative 24 hours
Peak Expiratory Flow Rate( PEFR)	maximum speed of expiration as measured with a peak flow meter	postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for first analgesic requirement	Time between end of surgery and patients first analgesic demand	24 hours
ambulation time	first postoperative mobilization time of the patient	5 days
length of hospital stay	day of hospitalization	1 week
Rikert Agitation Scale	postoperative agitation score; unarousable; very sedated; sedated; calm and cooperative; agitated; very agitated; dangerous agitation	24 hours
nausea and vomiting	incidence of nausea and vomiting	24 hours
patient satisfaction with anesthesia and analgesia	4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)	24 hour
starting oral intake	first oral intake	48 hours
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.	postoperative 24 hours
surgeon satisfaction with anesthesia and analgesia	4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)	24 hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Semih Baskan, 2, Ankara City Hospital Anesthesiology Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: E1-20-315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No