Erector Spinae Regional Anesthesia for Pain Control

NCT05794828 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HSC20220911H
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Pain Management

Keywords

Erector spinae plane block; ESPB; Pain reduction

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Erector Spinae Plane Block (ESP) administration

EXPERIMENTAL

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.

Drug: Bupivacaine Injection

Interventions

Bupivacaine Injection DRUG

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

Also known as: Bupivacaine Hydrochloride Injection

Erector Spinae Plane Block (ESP) administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Posterior/lateral rib or vertebral fractures
• Pancreatitis or pancreatic cancer
• Renal colic
• Back pain

You may not qualify if:

• Unstable vitals
• Infection or open wound over insertion site
• Prior allergic reaction to local anesthetic
• Pregnant females
• Patients \<18 years old
• Altered mentation

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (4)

Crozer Chester Medical Center

Ridley Park, Pennsylvania, 19078, United States

Location

Crozer Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Morgan Ritz, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group open label assignment

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: September 15, 2023
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion, after acceptance into a peer reviewed journal

Locations

US (4)