Erector Spinae Plane Block for GI Cancer Pain

(EGIPT Trial)

Recruiting at 3 trial locations

Overseen By Michael Shalaby, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Incarcerated, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 24 hours

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with severe stomach pain caused by gastrointestinal (GI) cancer. It will test a pain relief method called an erector spinae plane block (ESPB), a type of regional anesthesia. The trial will compare this method's effectiveness against standard treatments by evaluating pain relief, opioid use, and hospital stay length. This trial may suit individuals with GI cancer who experience severe abdominal pain and have a CT scan confirming the pain is cancer-related. As an unphased trial, the study offers an opportunity to explore innovative pain relief methods for GI cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for patients with GI cancer pain?

A previous study found the erector spinae plane block (ESPB) safe and effective for managing pain after abdominal surgeries. This relatively simple technique has been used for pain relief. Another study suggested that ESPB could reduce sudden pain in patients with cancer-related abdominal pain. However, some researchers caution that while ESPB can help with cancer pain, more high-quality research is needed to fully understand its safety. So far, patients generally tolerate ESPB well, but more research is necessary to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard pain management options for gastrointestinal cancer, such as opioids and NSAIDs, the Erector Spinae Plane Block (ESPB) offers a more targeted approach. Researchers are excited about ESPB because it delivers local anesthesia directly to the nerves responsible for abdominal pain, potentially reducing the need for systemic medications and their side effects. This method could offer quicker pain relief and improve the quality of life for patients dealing with this challenging condition.

What evidence suggests that the erector spinae plane block is effective for GI cancer pain?

Studies have shown that the erector spinae plane block (ESPB) might help manage cancer-related pain, particularly for those with stomach or digestive issues. Some research suggests that ESPB could alleviate sudden pain in patients with severe abdominal cancer, potentially aiding their return to daily activities. Although evidence for using ESPB specifically for cancer pain remains limited and varies in quality, its use in emergency rooms for various types of abdominal pain is increasing. Overall, ESPB shows promise, but realistic expectations about its safety and effectiveness are important. Participants in this trial will receive the ESPB to evaluate its effectiveness in managing abdominal pain in gastrointestinal cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Shalaby, MD

Principal Investigator

University of Pennsylvania Department of Emergency Medicine

Are You a Good Fit for This Trial?

This trial is for patients with gastrointestinal malignancies who are experiencing severe abdominal pain. They must be visiting one of the four Penn Medicine emergency departments. The study excludes certain individuals based on criteria not specified here.

Inclusion Criteria

I am over 18 and have severe stomach pain due to GI cancer.

My recent CT scan shows my abdominal pain is likely caused by cancer.

Exclusion Criteria

Allergy to ropivacaine or history of local anesthetic systemic toxicity

Pregnancy

Incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the erector spinae plane block for abdominal pain management

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for opioid consumption, pain levels, and satisfaction with pain management

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Plane Block

Trial Overview The Erector Spinae Plane Block (ESPB), a regional anesthesia technique, is being tested to manage intractable abdominal pain in GI cancer patients. It will be compared to standard care using historical controls regarding opioid use and hospital stay length.

How Is the Trial Designed?

Group I: Treatment Arm -- Erector Spinae Plane Block Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11566050/

Erector spinae plane block for cancer pain relief: a systematic ... The evidence supporting the use of ESPB for cancer pain management is currently scarce, heterogeneous, and of low quality.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07211386

The Erector Spinae Plane Block For Gastrointestinal ... Patients with gastrointestinal malignancy and abdominal pain will receive the erector spinae plane block for their abdominal pain. Intervention/Treatment ...

3. annemergmed.com annemergmed.com/article/S0196-0644(24)00671-1/fulltext

215 Ultrasound-Guided Erector Spinae Plane Block for ... Our findings suggest that this block may break the acute pain response in patients with breakthrough intra-abdominal cancer pain, expediting the bridge back to ...

4. journals.lww.com journals.lww.com/ijpn/fulltext/2023/37020/erector_spinae_plane_block_for_cancer_pain___a.3.aspx

Erector Spinae Plane Block for Cancer Pain – A Scoping... The current literature suggests that the ESP block can be helpful in cancer pain management. However, caution must be exercised not to overestimate the safety.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0736467925003737

Ultrasound Guided Erector Spinae Plane Block for Pain ... Our findings demonstrate that ESPBs are increasingly used in the ED for a variety of indications, especially for visceral abdominal pain, rib ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/9010753

Erector Spinae Plane (ESP) Block for Postoperative Pain ... We found ESP blocks to be a safe, technically simple, and effective treatment for postoperative pain management after elective oncologic abdominal procedures.