Erector spinae plane block for abdominal pain from gastrointestinal cancer
Efficacy of the Erector Spinae Plane Block for Abdominal Pain From Gastrointestinal Malignancies
This study will try an erector spinae plane nerve block to reduce severe abdominal pain and opioid use in adults with gastrointestinal cancers who come to Penn Medicine emergency departments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 4 sites (Philadelphia, Pennsylvania and 3 other locations) |
| Trial ID | NCT07211386 on ClinicalTrials.gov |
What this trial studies
This project will offer an erector spinae plane block (ESPB), a regional anesthetic technique, to adults with GI malignancy who present to Penn Medicine EDs with intractable abdominal pain. Eligible patients receiving ESPB will be enrolled as a prospective cohort and compared to a matched historical control group of similar patients treated with standard ED analgesia. The primary outcome is total opioid use over 24 hours measured in milligram morphine equivalents (MMEs), with secondary outcomes including hospital length of stay and pre/post-block pain, function, and satisfaction at 24 hours. The ESPB will be performed by ED providers per institutional protocols already in use at UPHS.
Who should consider this trial
Good fit: Adults (over 18) with known gastrointestinal malignancy who present to a participating Penn Medicine ED with intractable abdominal pain and a same-day or recent CT showing a malignant source, who are medically stable and able to consent, are the intended participants.
Not a fit: Patients with non-malignant causes of pain, hemodynamic instability, allergy to ropivacaine or history of local anesthetic toxicity, pregnancy, incarceration, inability to consent, admission for serial abdominal exams, or prior enrollment are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the ESPB could lower opioid needs and pain levels and possibly shorten hospital stays for patients with cancer-related abdominal pain.
How similar studies have performed: Regional anesthesia techniques including ESPB have shown pain and opioid-sparing benefits in perioperative and acute pain case series and small trials, but high-quality evidence specifically for ED management of GI cancer pain is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients age \> 18 years old with GI malignancy presenting to a Penn Medicine ED with intractable abdominal pain. 2. 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: 1. Allergy to ropivacaine or history of local anesthetic systemic toxicity. 2. Pregnancy 3. Incarcerated 4. Patients being admitted for serial abdominal examinations to determine their surgical course. 5. Altered mental status or inability for patient to consent for the procedure 6. Hemodynamic instability 7. Previously enrolled in the study
Where this trial is running
Philadelphia, Pennsylvania and 3 other locations
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Hospital of the University of Pennsylvania -- Cedar Avenue — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael Shalaby, MD — University of Pennsylvania Department of Emergency Medicine
- Study coordinator: Umar Aulia, AB
- Email: umar.aulia@pennmedicine.upenn.edu
- Phone: 267-624-4394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.