Gastrointestinal MalignancyEGIPTNCT07211386
The Erector Spinae Plane Block For Gastrointestinal Malignancy Pain Treatment (EGIPT)
A study testing Erector Spinae Plane Block in people with Gastrointestinal Malignancy and Pain Control, run by Abramson Cancer Center at Penn Medicine at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Malignancy, Pain Control
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Dec 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Umar Aulia, AB, 267-624-4394, umar.aulia@pennmedicine.upenn.edu
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Umar Aulia, AB, 267-624-4394, umar.aulia@pennmedicine.upenn.edu
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Umar Aulia, AB, 267-624-4394, umar.aulia@pennmedicine.upenn.edu
- Recruiting
Hospital of the University of Pennsylvania -- Cedar Avenue
Philadelphia, Pennsylvania, 19143
Umar Aulia, AB, 267-624-4394, umar.aulia@pennmedicine.upenn.edu
About this study
Official title: Efficacy of the Erector Spinae Plane Block for Abdominal Pain From Gastrointestinal Malignancies
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Malignancy, Pain Control
- Being tested
- Erector Spinae Plane Block
- Keywords
- Gastrointestinal malignancy, pain control, nerve block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
We will track the amount of opioids consumed within 24 hours by patients who received the erector spinae plane block
Measured: 24 hours
Opioid Consumption
We will track the amount of opioids consumed within 24 hours by participants who receive the erector spinae plane block.
Measured: 24 hours
Secondary outcomes (3)
Length of Stay
We will track the total length of stay (emergency department + hospital) for patients who receive the erector spinae plane block
Measured: 1 week
Pain Levels
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.
Measured: 30 minutes
Revised American Pain Society Patient Outcome Questionnaire
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start11 Dec 2025 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MalignancyStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Shalaby, University of Pennsylvania
- Investigators
- Michael Shalaby, MD, Principal investigator, University of Pennsylvania Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211386
- Sponsor's protocol ID
- UPCC 27224
- Acronym
- EGIPT
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40402045Forero 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.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Erector Spinae Plane Block for Abdominal Pain From Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT07211386
- Acronym / sponsor ID
- EGIPT / UPCC 27224
- Conditions
- Gastrointestinal Malignancy, Pain Control
- Keywords
- Gastrointestinal malignancy, pain control, nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 11 Dec 2025 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm -- Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockPatients with gastrointestinal malignancy and abdominal pain will receive the erector spinae plane block for their abdominal pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Erector Spinae Plane BlockThe 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 | Procedure or surgery | Treatment Arm -- Erector Spinae Plane Block |
Primary outcome
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
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.
3 secondary outcomes
Length of Stay
Time frame: 1 week
Pain Levels
Time frame: 30 minutes
Revised American Pain Society Patient Outcome Questionnaire
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 40402045Gawel 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.
- Background: PubMed 27501016Forero 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.
- Individual participant dataSharing planned: No
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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.
Michael Shalaby, MD principal investigator
University of Pennsylvania Department of Emergency Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Gastrointestinal Malignancy and Pain Control, run by Abramson Cancer Center at Penn Medicine 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Nov 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umar Aulia, AB (267-624-4394, umar.aulia@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211386, which also lists 2 linked publications.
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 28 Nov 2025.