Pain Blocks for Open Abdominal Surgery

Overseen By Ehab Farag, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Hepatic disease, Chronic kidney disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for pain relief in open abdominal surgery?

Research shows that the oblique subcostal transversus abdominis plane (OSTAP) block is effective for pain relief in upper abdominal surgeries, like laparoscopic cholecystectomy, suggesting it may also help with pain after open abdominal surgery. ^{1 2 3 4 5}

Is the subcostal transversus abdominis plane block safe for humans?

The subcostal transversus abdominis plane (TAP) block is generally considered safe and effective for pain relief in abdominal surgeries, but there has been a report of a severe abdominal wall infection following its use, which suggests that while rare, complications can occur. ^{1 3 6 7 8}

How is the External Oblique Intercostal Fascial Plane Block and Oblique Subcostal Transversus Abdominis Plane Block treatment different from other treatments for pain after open abdominal surgery?

This treatment is unique because it uses specific regional anesthetic techniques, like the External Oblique Intercostal Block and the Oblique Subcostal Transversus Abdominis Plane Block, to target pain in the upper abdominal area, potentially offering more focused pain relief compared to traditional methods. ^{1 2 3 4 9}

What is the purpose of this trial?

The investigators propose a single-center, assessor blinded, randomized control trial to compare the efficacy of external oblique fascial plane (EOIFP) block versus Oblique Subcostal Transversus Abdominis Plane (OSTAP) block for patients undergoing open upper abdominal surgery at Cleveland Clinic Main Campus.

Research Team

Ehab Farag, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: External Oblique Intercostal Fascial Plane block Experimental Treatment 1 Intervention

Researchers will perform the External Oblique Intercostal Fascial Plane block using sterile technique under ultrasound guidance. Once the target is visualized, a 20-gauge, 4-inch echogenic needle will be advanced in-plane to the fascial plane. 5 ml of 0.9% normal saline will be injected through the needle to open the fascial plane and then a single dose (10 ml) of liposomal bupivacaine mixed with 20 mL of bupivacaine 0.25% will be injected on each side.

Group II: Oblique Subcostal Transversus Abdominis Plane Block Active Control 1 Intervention

Researchers will perform the Oblique Subcostal Transversus Abdominis Plane Block using sterile technique under ultrasound guidance. Once the target is visualized, a 20-gauge, 4-inch echogenic needle will be advanced in-plane to the fascial plane. 5 ml of 0.9% normal saline will be injected through the needle to open the fascial plane and then a single dose (10 ml) of liposomal bupivacaine mixed with 20 mL of bupivacaine 0.25% will be injected on each side.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

The oblique subcostal transversus abdominis plane (OSTAP) block significantly reduced postoperative pain scores compared to standard care and the transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy, indicating its effectiveness as an analgesic method.

Patients receiving the OSTAP block required less rescue analgesics, specifically a reduced total fentanyl requirement, demonstrating its potential for improved pain management after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided oblique subcostal transversus abdominis plane block for analgesia after laparoscopic cholecystectomy: a randomized, controlled, observer-blinded study. Shin, HJ., Oh, AY., Baik, JS., et al.[2022]

The external oblique intercostal (EOI) block technique was shown to effectively target intercostal nerves T7 to T10, providing reliable analgesia for the upper midline and lateral abdominal wall, as demonstrated in a cadaveric study.

In a cohort of 22 patients, the EOI block resulted in consistent dermatomal sensory blockade from T6 to T10, indicating its potential for effective pain management in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Elsharkawy, H., Kolli, S., Soliman, LM., et al.[2022]

In a study involving 60 patients undergoing laparoscopic cholecystectomy, both the Erector Spinae Plane Block (ESPB) and Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) provided effective postoperative analgesia, significantly reducing pain intensity in the first 3 hours compared to a control group.

Both ESPB and OSTAP resulted in lower consumption of analgesics and reduced need for rescue pain relief, demonstrating that these regional anesthetic techniques can enhance the quality of multimodal analgesia after upper abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: Randomized, Controlled, Prospective Study. Tulgar, S., Kapakli, MS., Kose, HC., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. Oksar, M., Koyuncu, O., Turhanoglu, S., et al.[2018]

The external oblique intercostal (EOI) block demonstrated effective postoperative analgesia in three different surgeries, resulting in low pain scores and minimal opioid use in the first 72 hours for all patients.

Due to its broad innervation area and ease of application, the EOI block is suggested to be a valuable option for upper abdominal analgesia, particularly for obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Coşarcan, SK., Erçelen, Ö.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Abdominal Wall Infection After Subcostal Transversus Abdominis Plane Block: A Case Report. Hang, D., Weich, D., Anderson, C., et al.[2021]

In a study of 60 children aged 3-10 undergoing open inguinal hernia repair, the use of a transversus abdominis plane (TAP) block significantly reduced serum cortisol and blood glucose levels during and after surgery, indicating a lower neuroendocrine stress response compared to general anesthesia alone.

The TAP block also provided better quality of analgesia and reduced the need for postoperative rescue analgesia, demonstrating its effectiveness as part of a multimodal pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair. Abu Elyazed, MM., Mostafa, SF., Abdullah, MA., et al.[2017]

The subcostal transverse abdominis plane (SCTAP) block offers superior pain relief for upper abdominal surgeries compared to the traditional transverse abdominis plane block, making it a more effective option for postoperative analgesia.

When combined with a four-quadrant transverse abdominis plane block, the SCTAP block can provide sufficient pain management for major abdominal surgeries, enhancing overall patient comfort during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Soliz, JM., Lipski, I., Hancher-Hodges, S., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. Mankikar, MG., Sardesai, SP., Ghodki, PS.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound-guided oblique subcostal transversus abdominis plane block for analgesia after laparoscopic cholecystectomy: a randomized, controlled, observer-blinded study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Evaluation of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: Randomized, Controlled, Prospective Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Severe Abdominal Wall Infection After Subcostal Transversus Abdominis Plane Block: A Case Report. [2021]

7. France pubmed.ncbi.nlm.nih.gov

The effect of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. [2020]

9. India pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. [2022]