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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05794828
Other study ID # HSC20220911H
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 15, 2023
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source The University of Texas Health Science Center at San Antonio
Contact Morgan Ritz, MD
Phone 972-757-2495
Email ritzm@uthscsa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion


Description:

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. They will rate their pain before and 30 minutes after the procedure using the ordinal categorical data on a numeric pain scale. Total patient opiate use will be gathered up to 8 hours after block completion.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Posterior/lateral rib or vertebral fractures - Pancreatitis or pancreatic cancer - Renal colic - Back pain Exclusion Criteria: - Unstable vitals - Infection or open wound over insertion site - Prior allergic reaction to local anesthetic - Pregnant females - Patients <18 years old - Altered mentation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Injection
Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously

Locations

Country Name City State
United States Crozer Chester Medical Center Ridley Park Pennsylvania
United States University Hospital San Antonio Texas
United States Crozer Chester Medical Center Upland Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scale Rating Change in pain scale rating assessed by the participants on a scale from 0-10 with 0 indicating no pain and 10 indicating the most severe pain. Baseline to study procedure end (approximately 30 minutes)
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