Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

Not Applicable

• Conditions: Erector Spinae Plane Block; Nephrolithotomy, Percutaneous; Postoperative Pain
• Interventions: Procedure: erector spinae block

• Registration Number: NCT04474873
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-06-28
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2:ESPB	erector spinae block	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

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	postoperative 24 hours	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	postoperative 24 hours	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)	postoperative 24 hours	maximum speed of expiration as measured with a peak flow meter

Secondary Outcome Measures

Name	Time	Method
nausea and vomiting	24 hours	incidence of nausea and vomiting
ambulation time	5 days	first postoperative mobilization time of the patient
length of hospital stay	1 week	day of hospitalization
Rikert Agitation Scale	24 hours	postoperative agitation score; 1. unarousable; 2. very sedated; 3. sedated; 4. calm and cooperative; 5. agitated; 6. very agitated; 7. dangerous agitation
Time for first analgesic requirement	24 hours	Time between end of surgery and patients first analgesic demand
patient satisfaction with anesthesia and analgesia	24 hour	4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
starting oral intake	48 hours	first oral intake
urinary catheter releated pain score(Visual Analog Scale)	postoperative 24 hours	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	24 hour	4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey