Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

NCT04474873 | Unknown

• 1 other identifier: E1-20-315
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Nephrolithotomy, Percutaneous; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Time for first analgesic requirement

  24 hours

• ambulation time

  5 days

• length of hospital stay

  1 week

• Rikert Agitation Scale

  24 hours

• nausea and vomiting

  24 hours

Study Arms (2)

Group 1:Conventional intravenous analgesia

NO INTERVENTION

Conventional intravenous analgesia applied according to surgeon's preference

Group 2:ESPB

ACTIVE COMPARATOR

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

Interventions

erector spinae block PROCEDURE

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.

Group 2:ESPB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing PNL between 18-65 years old

You may not qualify if:

• 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/

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31620856 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Semih Baskan, 2

  Ankara City Hospital Anesthesiology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 17, 2020
• Study Start: March 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 30, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)