100 Participants Needed

Pain Blocks for Open Abdominal Surgery

FR
EF
Overseen ByEhab Farag, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which pain block method is more effective for individuals undergoing open upper abdominal surgery. Researchers are comparing two pain management blocks: the External Oblique Intercostal Fascial Plane Block and the Oblique Subcostal Transversus Abdominis Plane Block. The trial targets patients scheduled for surgeries like gastrectomy or hepatectomy, who anticipate needing strong pain relief, such as opioids, for at least 48 hours post-surgery. Participants should not have severe liver or kidney conditions or be scheduled for certain other types of surgeries. As an unphased trial, this study allows patients to contribute to medical knowledge and potentially enhance pain management techniques for future surgeries.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the External Oblique Intercostal Fascial Plane (EOIFP) block and the Oblique Subcostal Transversus Abdominis Plane (OSTAP) block are generally safe and effective for managing pain during surgeries.

Studies have found that the EOIFP block reduces the need for opioids and decreases pain after surgery, particularly in patients with obesity. This approach manages pain effectively without over-relying on medications that might have more side effects.

For the OSTAP block, research indicates it provides excellent pain relief after surgeries like stomach surgery and minimally invasive procedures. It also effectively relieves pain after open umbilical hernia repair. Ultrasound guidance enhances the procedure's precision and safety.

Both treatments use a combination of liposomal bupivacaine and bupivacaine, well-known anesthetics commonly used in medical settings, adding an extra layer of safety. Overall, evidence supports that both blocks are safe and effective for managing pain in abdominal surgeries.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to manage pain after open abdominal surgery. Unlike traditional pain management options like opioids, which can have significant side effects, both the External Oblique Intercostal Fascial Plane Block and the Oblique Subcostal Transversus Abdominis Plane Block use ultrasound guidance to deliver a mix of liposomal bupivacaine and bupivacaine 0.25% directly to specific fascial planes. This targeted delivery method not only aims to reduce pain more effectively but also minimizes the need for systemic pain medication, potentially leading to fewer side effects and a quicker recovery. By focusing on these precise injection techniques, researchers hope to improve postoperative pain control significantly.

What evidence suggests that this trial's treatments could be effective for open abdominal surgery?

This trial will compare the effectiveness of two pain management techniques for open abdominal surgery. Research has shown that the Oblique Subcostal Transversus Abdominis Plane (OSTAP) block, one of the treatments participants may receive, effectively reduces pain after surgeries like stomach and liver operations. Studies have found it provides significant pain relief after abdominal surgeries. Meanwhile, the External Oblique Intercostal Fascial Plane (EOIFP) block, another treatment option in this trial, has helped with early recovery and reduced pain after surgery. One study even found it to be better than the OSTAP block for pain relief in upper abdominal surgeries. Both blocks numb the nerves in the abdominal area to reduce post-surgery pain, making them promising options for those undergoing abdominal surgery.24678

Who Is on the Research Team?

EF

Ehab Farag, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients who are scheduled for open upper abdominal surgery. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

My health is good to moderately impaired.
Written informed consent
Anticipated hospitalization of three nights
See 2 more

Exclusion Criteria

I have had surgery on my kidney or lower abdomen.
My liver enzymes are twice the normal level.
Allergic reaction to study medications
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the EOIFP block or the OSTAP block under ultrasound guidance during their upper abdominal surgery

Surgery day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored postoperatively for pain management and recovery, with adjustments to analgesic management as necessary

3 days
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • External Oblique Intercostal Fascial Plane Block
  • Oblique Subcostal Transversus Abdominis Plane Block
Trial Overview The study is testing two types of nerve block techniques: EOIFP Block and OSTAP Block, to see which one is more effective in managing pain after open abdominal surgery. It's a randomized control trial where participants will be assigned to either technique by chance.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: External Oblique Intercostal Fascial Plane blockExperimental Treatment1 Intervention
Group II: Oblique Subcostal Transversus Abdominis Plane BlockActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Published Research Related to This Trial

Both intercostal-iliac transversus abdominis plane (TAP) and oblique subcostal TAP (OSTAP) blocks significantly improved postoperative pain management in patients undergoing laparoscopic cholecystectomy, leading to lower visual analog scale (VAS) scores and reduced analgesic consumption compared to the control group.
Among the two techniques, the OSTAP block was particularly effective, resulting in lower VAS scores than both the TAP block and the control group, indicating it may provide superior pain relief in this surgical context.
Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy.Oksar, M., Koyuncu, O., Turhanoglu, S., et al.[2018]
Transversus abdominis plane (TAP) blocks are generally considered safe and effective for pain relief in abdominal surgeries, making them a popular choice for perioperative analgesia.
However, there is a rare risk associated with TAP blocks, as demonstrated in a case where a patient developed an unusual abdominal wall abscess following the procedure, leading to complications in recovery.
Severe Abdominal Wall Infection After Subcostal Transversus Abdominis Plane Block: A Case Report.Hang, D., Weich, D., Anderson, C., et al.[2021]
The transversus abdominis plane (TAP) block using ropivacaine significantly reduced post-operative pain levels (measured by visual analogue score) for 24 hours after caesarean section compared to a control group receiving normal saline.
Patients receiving the TAP block experienced a longer time before needing additional pain relief (rescue analgesia), extending from 4.1 hours to 9.53 hours, and required less tramadol in the first 24 hours, indicating improved pain management.
Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section.Mankikar, MG., Sardesai, SP., Ghodki, PS.[2022]

Citations

The impact of external oblique intercostal block on early ...The aim of this study was to investigate the effects of external oblique intercostal nerve block (EOIB) on early postoperative pain and recovery ...
Ultrasound-guided external oblique intercostal plane block ...This study aims to evaluate and compare the efficacy of the external oblique intercostal plane (EOI) block and the subcostal TAP block in individuals who have ...
External Oblique—Intercostal (EOI) Fascial Plane Block for ...External oblique intercostal block vs erector spinae block for open upper abdominal surgery: a prospective study. Unpublished data. 2025. 12 ...
Modified approach to external oblique intercostal blockWe present a modified external oblique intercostal block for complete lateral abdominal analgesia with a single injection.
The impact of external oblique intercostal block on early ...The aim of this study was to investigate the effects of external oblique intercostal nerve block (EOIB) on early postoperative pain and recovery ...
Ultrasound-Guided External Oblique Intercostal Plane ...The results of the current study demonstrated that bilateral EOI block reduced postoperative opioid consumption and postoperative pain in patients with obesity.
Bilateral External Oblique Intercostal Plane Bock (EOIPB) ...The current study is designed to investigate the analgesic potentials of two modalities of abdominal blocks where local anesthetics is injected in the ...
OP051 Comparison of ultrasound guided external oblique ...Conclusions Ultrasound guided EOI Plane Block is a better analgesic technique than Subcostal TAP Block in patients undergoing upper abdominal surgeries with ...
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