Pain ManagementEarly Phase 1NCT05794828
Erector Spinae Regional Anesthesia for Pain Control
A Early Phase 1 study testing Bupivacaine Injection in people with Pain Management, run by The University of Texas Health Science Center at San Antonio at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2023to 18 Feb 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior/lateral rib or vertebral fractures
- Pancreatitis or pancreatic cancer
- Renal colic
- Back pain
Who cannot join
- Unstable vitals
- Infection or open wound over insertion site
- Prior allergic reaction to local anesthetic
- Pregnant females
- Patients <18 years old
- Altered mentation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Crozer Chester Medical Center
Ridley Park, Pennsylvania, 19078
University Hospital
San Antonio, Texas, 78229
Baylor Scott & White
Temple, Texas, 76508
Crozer Chester Medical Center
Upland, Pennsylvania, 19013
About this study
Official title: 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
Read the 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.
- Conditions
- Pain Management
- Being tested
- Bupivacaine Injection
- Keywords
- Erector spinae plane block, ESPB, Pain reduction
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine InjectionDrug
Also called Bupivacaine Hydrochloride Injection
Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESP) administration | Experimental | Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. Receives: Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study procedure end (approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Sep 2023
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group open label assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Ritz, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794828
- Sponsor's protocol ID
- HSC20220911H
- Status last verified
- Aug 2025
- First submitted
- 20 Mar 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared in a peer reviewed publication after acceptance by the journal
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Regional Anesthesia for Pain Control in the Emergency Department
- ClinicalTrials.gov ID
- NCT05794828
- Acronym / sponsor ID
- HSC20220911H
- Conditions
- Pain Management
- Keywords
- Erector spinae plane block, ESPB, Pain reduction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group open label assignment
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESP) administration | Experimental | Drug: Bupivacaine InjectionPatients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Posterior/lateral rib or vertebral fractures
- Pancreatitis or pancreatic cancer
- Renal colic
- Back pain
Key exclusion criteria (6 listed)
- Unstable vitals
- Infection or open wound over insertion site
- Prior allergic reaction to local anesthetic
- Pregnant females
- Patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine InjectionAlso: Bupivacaine Hydrochloride InjectionBucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously | Drug | Erector Spinae Plane Block (ESP) administration |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared in a peer reviewed publication after acceptance by the journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Ritz, MD principal investigator
The University of Texas Health Science Center at San Antonio
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupivacaine Injection in people with Pain Management, run by The University of Texas Health Science Center at San Antonio at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale Rating (time frame: Baseline to study procedure end (approximately 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.