Comparing pain relief methods for patients undergoing vascular surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Kevin Finkel, MD — Hartford Hospital
• Study coordinator: Aseel Walker, MD
• Email: aseel.walker@hhchealth.org
• Phone: (860) 972-1778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remimazolam vs propofol for stable blood pressure during thoracic/abdominal endovascular aortic repair

  This trial tests whether remimazolam keeps blood pressure steadier than propofol during TEVAR or EVAR in adults.

  Recruiting Phase 4 Seoul National University Hospital · Seoul · NCT07806006

• Predictors of Major Adverse Limb Events After Iliac Artery Stenting

  This study tests what factors predict serious limb-related problems after iliac artery stenting in adults with peripheral artery disease.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Mi · NCT07672249

• Prospective cardiac surgery cohort to improve perioperative care

  A multi-center study will test a large, forward-looking database of adults undergoing heart surgery to better understand what affects short- and long-term outcomes.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07662317

• Aortic Diseases and Quality of Life: How Work Ability is Affected

  This observational study tests how living with aortic diseases affects quality of life, fatigue, mental well-being, and the ability to work in adults aged 18 to 70.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07479186

• Using AI to measure aortic size from CT scans

  This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

  Recruiting Aiatella Oy · Chapel Hill, North Carolina and 2 other locations · NCT07438327

• Long-term follow-up of Intergard vascular grafts and patches

  This registry will see how Intergard grafts and patches perform and stay safe over time in adults who had bypass, repair, or replacement of the aorta, carotid, or peripheral arteries.

  Recruiting at 5 sites Intervascular · Hershey, Pennsylvania and 4 other locations · NCT07322913

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.