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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05625802
Other study ID # HUM00219913
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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