Comparing two types of nerve blocks for pain management in upper abdominal surgery
A Feasibility Pilot Study Assessing the Effects of External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block for Upper Abdominal Surgery: A Randomized, Controlled Trial
This study is testing which of two types of nerve blocks can help reduce pain better for people recovering from open upper abdominal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06409156 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different nerve blocks, the external oblique fascial plane (EOIFP) block and the Oblique Subcostal Transversus Abdominis Plane (OSTAP) block, in managing postoperative pain for patients undergoing open upper abdominal surgery. Conducted at the Cleveland Clinic Main Campus, the study will randomly assign participants to receive one of the two blocks, with both patients and outcome assessors blinded to the group assignments. The blocks will be performed under ultrasound guidance, and the study will evaluate pain management outcomes over the postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with ASA physical status 1-3 scheduled for elective open upper abdominal surgery requiring a supraumbilical incision.
Not a fit: Patients with chronic hepatic or kidney disease, pregnant or breastfeeding women, or those undergoing lower abdominal surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing upper abdominal surgeries, potentially reducing opioid use and enhancing recovery.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent; * 18-85 years old; * ASA Physical Status 1-3 * Scheduled for elective open upper abdominal surgery with supraumbilical incision (gastrectomy, hepatectomy, pancreatectomy, splenectomy, supraumbilical ventral hernia repair). * Anticipated hospitalization of three nights; * Expected requirement for parenteral opioids for at least 48 hours for postoperative pain Exclusion Criteria: * Hepatic disease, e.g. twice the normal levels of liver enzymes; * Chronic kidney disease according to GFR (may be stage 3 or worse as defined by a GFR \<60 * Allergic reaction to study medications; * Women who are pregnant or breastfeeding; * Nephrectomy or lower abdominal surgeries such as hysterectomy, colorectal surgeries * Patient refusal
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ehab Farag, MD — The Cleveland Clinic
- Study coordinator: Fabio Rodriguez, MD
- Email: rodrigf3@ccf.org
- Phone: 216-444-9950
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.