- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794828
Erector Spinae Regional Anesthesia for Pain Control
August 26, 2025 updated by: The University of Texas Health Science Center at San Antonio
Erector Spinae Regional Anesthesia for Pain Control in the Emergency Department
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
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Ridley Park, Pennsylvania, United States, 19078
- Crozer Chester Medical Center
-
Upland, Pennsylvania, United States, 19013
- Crozer Chester Medical Center
-
-
Texas
-
San Antonio, Texas, United States, 78229
- University Hospital
-
Temple, Texas, United States, 76508
- Baylor Scott & White
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Erector Spinae Plane Block (ESP) administration
Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.
|
Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scale Rating
Time Frame: Baseline to study procedure end (approximately 30 minutes)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Morgan Ritz, MD, University of Texas Health Science Center San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2023
Primary Completion (Actual)
February 18, 2025
Study Completion (Actual)
February 18, 2025
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 26, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20220911H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be shared in a peer reviewed publication after acceptance by the journal
IPD Sharing Time Frame
At study completion, after acceptance into a peer reviewed journal
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain Management
-
Yeditepe University HospitalCompletedPain Management | Breast Augmentation | Pain Management After Surgery | Pain Management in Postoperative CareTurkey
-
Kutahya Health Sciences UniversityBartın Unıversity; Mardin Artuklu UniversityCompletedPain Management | Nonpharmalogical Pain Management | Children Pain ManagementTurkey
-
Wolfson Medical CenterUnknownPain Management | Post Surgical Management | Inflamation ManagementIsrael
-
Assiut UniversityNot yet recruitingPain Management | Neonates Pain Management
-
Sintetica SACross S.A.CompletedPhase 1: Pain Management | Phase 2: Pain ManagementSwitzerland
-
Misr University for Science and TechnologyActive, not recruitingPain | Pain Management | Pain Management in Postoperative CareEgypt
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruiting
-
Zagazig UniversityCompletedPostoperative Pain ManagementEgypt
-
Istanbul Arel UniversityActive, not recruitingInfant Pain ManagementTurkey (Türkiye)
-
Värmland County Council, SwedenSykehuset Telemark; Örebro University, Sweden; Dalarna County Council, Sweden; Region... and other collaboratorsCompletedInfant Pain Management | Parent-driven Pain ManagementSweden
Clinical Trials on Bupivacaine Injection
-
Jiangsu HengRui Medicine Co., Ltd.CompletedPostoperative Local AnalgesiaChina
-
Second Affiliated Hospital of Nanchang UniversityRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingLocal Analgesia Via Nerve BlockChina
-
Ataturk UniversityEnrolling by invitationHip Osteoarthritis | Osteonecrosis of the Femoral Head | Avascular Necrosis of Femur Head | Dysplasia of Hip Joint | Hip SurgeriesTurkey (Türkiye)
-
Broward HealthCompleted
-
University of Texas Southwestern Medical CenterCompleted
-
University of South FloridaCompletedPain, Postoperative | Carpal Tunnel SyndromeUnited States
-
Centre intégré universitaire de santé et de services...Recruiting
-
Antalya Training and Research HospitalNot yet recruitingStellate Ganglion BlockTurkey (Türkiye)
-
Peking University First HospitalCompletedAnalgesia | Paravertebral Block | Regional Block | Local AnestheticsChina