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NCT Number: NCT07211386

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Primary objective: To determine whether patients with GI malignancy receiving an ESPB for intractable abdominal pain consume less opioids (measured in MMEs) in a 24-hour period compared to standard of care analgesia.

Secondary objectives:

To determine whether patients who receive an ESPB have shorter hospital LOS compared to standard of care analgesia.

Within the cohort receiving the ESPB, to determine whether there was a change in pain level as measured by the numeric rating scale (NRS) pre/post block.

Exploratory: Within cohort receiving the ESPB, to determine level of patient satisfaction and functionality as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)

Patients with a GI malignancy presenting with intractable abdominal pain. To any of 4 EDs, (1) Hospital of the University of Pennsylvania (HUP), (2) Penn Presbyterian Medical Center (PPMC), (3) Pennsylvania Hospital (PAH), and (4) HUP Cedar (Cedar) Exclusion criteria: pregnant, incarcerated, admissions for serial abdominal examinations, small bowel obstruction, sepsis, altered mental status, hemodynamic instability.

Participants will receive an ESPB, a nerve block performed by injecting anesthetic between a single spinal transverse process and the erector spinae muscle complex (Forero et al). Anesthetic reaches the dorsal nerve root ganglia but also diffuses anteriorly to the paravertebral space which contains the thoracic sympathetic ganglia (Chin et al). Visceral afferent fibers transmit pain signals arising from the stomach to midway through the sigmoid colon utilizing the same anatomical conduit as sympathetic efferent fibers (Moore et al). While physically associated, they travel in the reverse direction of the sympathetic efferents and are functionally distinct. From the abdominal viscera to spinal cord, visceral afferents transmit pain signals first through the peri-aortic autonomic plexuses and prevertebral ganglia, then along the splanchnic nerves to reach the sympathetic trunk, where they travel via the white rami communicantes to reach the spinal nerves of T5 to L2, before finally being conducted centrally. Thus, anesthetizing the thoracolumbar spinal nerves and sympathetic chain, via an ESPB performed between the levels of T5 and L2, should block abdominal visceral pain signaling, and may provide significant analgesia for patients with abdominal pain from GI malignancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Opioid Consumption

    Time frame: 24 hours

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

  2. Opioid Consumption

    Time frame: 24 hours

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

Secondary outcomes

  1. Length of Stay

    Time frame: 1 week

    We will track the total length of stay (emergency department + hospital) for patients who receive the erector spinae plane block

  2. Pain Levels

    Time frame: 30 minutes

    We will track the pain level (measured on a 0-10 Numeric Rating Scale) of participants who receive the erector spinae plane block, and we will compare the difference between their pain immediately before receiving the block and 30 minutes after receiving the block.

  3. Revised American Pain Society Patient Outcome Questionnaire

    Time frame: 24 hours

    We will administer a short 9 question survey graded on a 0-10 scale at 24 hours after participants receive the erector spinae plane block. This survey will assess their pain levels, satisfaction with the erector spinae plane block, ability to move in bed, and ability to move independently out of bed during the 24 hours after they received the erector spinae plane block.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Shalaby, MD

CONTACT

[email protected]

267-624-4394

Umar Aulia, AB

CONTACT

[email protected]

267-624-4394

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Efficacy of the Erector Spinae Plane Block for Abdominal Pain From Gastrointestinal Malignancies

Acronym: EGIPT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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