Comparing pain relief methods for patients undergoing vascular surgery

Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks And Catheters With Intermittent Hourly Boluses.

This study is testing whether a single shot of a new pain medication can help people having vascular surgery feel less pain compared to the standard pain relief method.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hartford Hospital (other)
• Locations: 1 site (Hartford, Connecticut)
• Trial ID: NCT05972018 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a single shot of liposomal bupivacaine/bupivacaine mixture against the standard care of ropivacaine delivered through bilateral rectus sheath catheters in patients undergoing open abdominal vascular surgery. Participants will be randomized to receive either treatment at the end of their surgery, and their pain levels will be assessed using the brief pain inventory-short form (BPI-SF) at 24-48 hours postoperatively. The study focuses on patients undergoing procedures such as abdominal aortic aneurysm repair and aims to determine which method provides better pain control.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision.

Not a fit: Patients requiring emergency vascular surgery or those with severe symptoms related to their vascular condition 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 major vascular surgeries.

How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18-80 years
2. Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision, including abdominal aortic aneurysm repair surgery (AAA), mesenteric artery bypass surgery, and aortobifemoral bypass surgery for aortic occlusive disease.
3. Patients who are able to speak and read English
4. Patients with American Society of Anesthesiology (ASA) physical status score I-IV
5. Patients who are admitted to the hospital and are incidentally discovered to require any of the aforementioned surgeries, being asymptomatic for vascular issues, and having their surgery scheduled no sooner than three days after admission, are also considered eligible.

Exclusion Criteria:

1. Emergency vascular reconstruction surgery., patients admitted to the hospital due to symptoms directly associated with their vascular condition, such as severe abdominal pain or a ruptured aneurysm causing bleeding, will be excluded.
2. Patients with contraindications to RSB, including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral RSBs, or infection at the injection site.
3. History of allergy to local anesthetics.
4. Weight \< 40 kg, as a combination of 20 mL of Bupivacaine 0.25% with 30 mL of LB is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
5. Patients who take long-acting opioid medication, or on continuous opioid use \> 50 MME per day for at least 30 days within 90 days prior to surgery.
6. Patients who have chronic pain syndrome with a recent preoperative consultation with the chronic pain service. Also, patients with distant metastatic cancers (e.g. bone, lung, brain) confirmed by CT scan.
7. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs (not including marijuana) or excessive alcohol consumption as defined as 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.
8. Lack or refusal to sign the study consent.
9. Patients who are unable to receive postoperative ropivacaine intermittent boluses within the first 5 days after surgery due to issues with their catheter (such as dislodgement, migration, or kinking) will be excluded from the final analysis.
10. Patients with a plan to undergo abdominal wall surgery, in addition to the vascular surgery that involves a mid-abdomen incision, such as abdominal wall reconstruction surgery. The additional abdominal wall incisions or interventions might have an impact on the study's pain, opioid, and LOS outcomes.

Where this trial is running

Hartford, Connecticut

• Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Kevin Finkel, MD — Hartford Hospital
• Study coordinator: Aseel Walker, MD

Conditions: Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion, Aortoiliac Occlusive Disease, Aortic Diseases, Open abdominal aortic repair surgery, Rectus Sheath Block, Rectus Sheath Block and Catheter, Liposomal Bupivacaine