Erector Spinae Plane Block for Uncomplicated Renal Colic

Kidney Stone Clinical Trial

Official title:

Erector Spinae Plane Block for Uncomplicated Renal Colic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625802
• Other study ID #: HUM00219913
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Carmen Colmenero Mahmood
• Phone: 734-647-0574
• Email: cico[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Imaging confirmation of urolithiasis on the index encounter or prior encounter within 7 days

• Patient received one dose of parenteral pain medication in the emergency department (ED)

Exclusion Criteria:

• Pregnancy or breastfeeding

• Prisoner or incarcerated individual

• Therapeutic anticoagulation or coagulopathy.

• Active treatment for urinary tract infection (either acute infection or chronic therapy)

• Prior spinal surgery in the thoracic region

• Allergy to local anesthetic or prior local anesthetic

• Soft tissue infection overlying the injection site

• Positive for coronavirus

• Inability to communicate verbally or read/write in English

• Currently taking strong CYP1A2 inhibitor (fluvoxamine, amiodarone, fluoroquinolones, etc.)

• Glucose-6-phosphate dehydrogenase deficiency (G6PD)

Related Conditions & MeSH terms

• Colic
• Kidney Calculi
• Kidney Stone
• Renal Colic

Intervention

Procedure:
• Erector Spinae Plane Block (ESPB)
Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance

Drug:
• Ropivacaine
0.5% ropivacaine

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED)	Data for this outcome will be collected via electronic health record query.	At ED discharge, approximately 1 day
Secondary	Change in pain	Pain ranked on a visual analog scale 1-10 where 10 indicates the most pain. Change is defined as the last pain score minus first pain score.	Baseline, 60 minutes following procedure
Secondary	Rate of admission to hospital	Data for this outcome will be collected via electronic health record query.	Up to 30-days
Secondary	Rate of 72-hour return to the Emergency Department (ED)	Data for this outcome will be collected via electronic health record query.	3 days