Erector Spinae Plane (ESP) Block for Renal Colic

Renal Colic Clinical Trial

Official title:

Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323175
• Other study ID #: IRB2021-00518
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Stony Brook University
• Contact: Michael Secko, MD
• Phone: 631-624-3849
• Email: Michael.Secko[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing standard of care to erector spinae plane block for acute renal colic pain.

Description:

Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years old
• ASA Level I and II
• flank pain concerning for renal colic in ED

Exclusion Criteria:

• pregnant women
• subjects unable to appreciate ESP block landmarks under ultrasound
• skin infection over needle site insertion
• Allergy to local anesthesia (lidocaine/Ropivacaine)
• bleeding disorders
• serious cardiac, lung, liver or kidney dysfunction
• history of spine surgery
• history of spinal infection
• history of epidural injection within 6 months
• acute exacerbation of serious mental disease
• unable to consent
• unable to communicate pain level

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Ropivacaine injection
Local anesthesia injected under ultrasound guidance

Other:
• Standard of care medications
Whatever the ED clinicians normally give for renal colic pain

Locations

Country	Name	City	State
United States	StonyBrook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aydin ME, Tekin E, Ahiskalioglu EO, Ates I, Karagoz S, Aydin OF, Ozkaya F, Ahiskalioglu A. Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Int J Clin Pract. 2021 Mar;75(3):e13789. doi: 10.1111/ijcp.13789. Epub 2020 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Pain before intervention	Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"	Before the ESP Block
Primary	Pain score at 10 minutes	Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"	10 minutes after the ESP Block
Primary	Pain score at 20 minutes	Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"	20 minutes after ESP Block
Primary	Pain score at 40 minutes	Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain	40 minutes after ESP Block
Primary	Pain score at 60 minutes	Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain	60 minutes after ESP Block
Secondary	Need for extra opiates	Record how much opioids patients receives starting after the ESP Block for both the "standard of care" patients and the ESP Block group	Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention