Health TrialsbyHealthPanel

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

ConditionsGastrointestinal MalignancyPain Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to ropivacaine or history of local anesthetic systemic toxicity.

Pregnancy

Incarcerated

Patients being admitted for serial abdominal examinations to determine their surgical course.

Trial design

Design model

Single group

Treatments tested in this trial

  • Erector Spinae Plane Block

    Procedure/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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment Arm -- Erector Spinae Plane BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Opioid Consumption

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

Time frame
24 hours
2

Opioid Consumption

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

Time frame
24 hours

Secondary outcomes

1

Length of Stay

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

Time frame
1 week
2

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.

Time frame
30 minutes
3

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.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

University of Pennsylvania

Sponsor institution

Source ClinicalTrials.gov
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