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NCT04213924 Clinical Trial

Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL

Pain Clinical Trial

Official title:
The Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04213924
Other study ID # ESPB for ESWL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date October 1, 2020

Study information
Verified date June 2020
Source Ataturk University
Contact Ahmet Yayik, MD
Phone 00905544259287
Email m_yayik@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date October 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

- chronic pain

- bleeding disorders

- renal or hepatic insufficiency

- patients on chronic non-steroidal anti-inflammatory medications

- emergency cases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml
Erector spinae plane block, 30 min before the ESWL procedure.
• 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously
5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure.

Locations
Country Name City State
Turkey Ataturk University Erzurum

Sponsors (1)
Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9. — View Citation

Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Opioid Consumption Opioid consumption during procedure Intraoperative 30 minutes
Secondary Visual Analog Pain Score Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) Intraoperative 30 minutes
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