The Erector Spinae Plane Block For Gastrointestinal Malignancy Pain Treatment (EGIPT)

NCT07211386 | Recruiting

• 1 other identifier: UPCC 27224
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

This study will target patients with gastrointestinal (GI) malignancy who present to any of 4 Penn Medicine emergency departments (EDs) with intractable abdominal pain. We will offer eligible patients an erector spinae plane block (ESPB), a regional anesthesia technique which is already offered to such patients in the ED at the University of Pennsylvania Healthy System (UPHS), for their intractable abdominal pain. We will compare the outcomes of this prospective cohort of patients to a matched historical control of patients with GI malignancy who were treated in the ED during the same time period as recruitment, but who were not recruited to partake in the study and who were managed with standard of care. Opioid consumption as measured by total milligram morphine equivalents (MMEs) over a 24-hour period and hospital length of stay (LOS) will be compared between cohorts. Additionally, for the ESPB cohort, pain level pre/post ESPB, and functionality and satisfaction with pain management at 24 hours will also be examined.

Conditions

Gastrointestinal Malignancy; Pain Control

Keywords

Gastrointestinal malignancy; pain control; nerve block

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption

  We will track the amount of opioids consumed within 24 hours by patients who received the erector spinae plane block

  24 hours

• Opioid Consumption

  We will track the amount of opioids consumed within 24 hours by participants who receive the erector spinae plane block.

  24 hours

Secondary Outcomes (3)

• Length of Stay

  1 week

• Pain Levels

  30 minutes

• Revised American Pain Society Patient Outcome Questionnaire

  24 hours

Study Arms (1)

Treatment Arm -- Erector Spinae Plane Block

EXPERIMENTAL

Patients with gastrointestinal malignancy and abdominal pain will receive the erector spinae plane block for their abdominal pain.

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

The abdominal viscera, from the stomach to midway through the sigmoid colon, derives its sensory innervation from afferent fibers that travel with, but are distinct from, the sympathetic nerve fibers from the 5th thoracic (T5) to the 2nd lumbar (L2) spinal levels (Moore et al). These fibers converge at the celiac plexus, located near the celiac artery and the aorta. From there, they bifurcate into the paravertebral sympathetic chain and subsequently ascend to the spinal cord and integrate into the central nervous system (Lohse et al). The celiac plexus block is an invasive procedure performed by an interventional anesthesiologist or palliative care specialist to lyse the celiac plexus and has been shown to reduce pain and opiate use in patients suffering from GI malignancy (Ashlock et al). While there are multiple methods to perform a celiac plexus block, it involves a steep needle trajectory either posteriorly through the retroperitoneum or anteriorly through the abdominal wall close

Treatment Arm -- Erector Spinae Plane Block

Eligibility Criteria

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

You may qualify if:

• Patients age \> 18 years old with GI malignancy presenting to a Penn Medicine ED with intractable abdominal pain.
• Same-day or recent CT scan of the abdomen / pelvis which demonstrates that the patient's abdominal pain can be reasonably attributed to a malignant source.

You may not qualify if:

• Allergy to ropivacaine or history of local anesthetic systemic toxicity.
• Pregnancy
• Incarcerated
• Patients being admitted for serial abdominal examinations to determine their surgical course.
• Altered mental status or inability for patient to consent for the procedure
• Hemodynamic instability
• Previously enrolled in the study

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (4)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Hospital of the University of Pennsylvania -- Cedar Avenue

Philadelphia, Pennsylvania, 19143, United States

RECRUITING

Related Publications (2)

• Gawel RJ, Kramer JA, Shalaby M. Ultrasound-Guided Erector Spinae Plane Block for Breakthrough Pancreatic and Hepatobiliary Malignancy Pain in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2025 May;9(2):129-133. doi: 10.5811/cpcem.39723.

  PMID: 40402045 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Shalaby, MD

  University of Pennsylvania Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umar Aulia, AB

CONTACT

267-624-4394; umar.aulia@pennmedicine.upenn.edu

Michael Shalaby, MD

CONTACT

267-624-4394; michael.shalaby@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: 25 patients with gastrointestinal malignancy and abdominal pain who present to any of the four emergency departments within the University of Pennsylvania Health System will be recruited to participate in the study. These patients will have their pain treated with the erector spinae plane block.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)