What is liposomal bupivacaine/bupivacaine studying for abdominal vascular surgery?

This trial is studying how a single dose of liposomal bupivacaine/bupivacaine compares to continuous ropivacaine infusion for pain control after open mid-abdominal vascular surgery. Researchers want to learn about safety, pain relief, opioid use, and hospital recovery. Hartford Hospital is leading this research to improve care options for these surgeries.

Who may be eligible for this abdominal vascular surgery clinical trial?

Adults aged 18 to 80 undergoing elective vascular surgery with an open mid-abdominal incision may be eligible. Participants must speak and read English and have an ASA physical status I-IV. Those with emergency surgery or allergies to local anesthetics are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this abdominal vascular surgery clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 18Years - 80Years

All Genders

ID05972018

Comparing Single-Dose Liposomal BupivacaineBupivacaine Blocks to Continuous Ropivacaine Catheters for Pain Control in Open Mid-Abdominal Vascular Surgery

Led by Hartford Hospital · Updated on 2025-09-03

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are assessing pain management methods in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. The study compares a single dose of liposomal bupivacainebupivacaine mixture administered via bilateral rectus sheath blocks to the standard care of bilateral rectus sheath catheters continuously infused with ropivacaine. The aim is to evaluate the safety, feasibility, and impact on postoperative complications, pain, opioid use, and hospital stay. Participants will receive either a single intraoperative dose of the liposomal bupivacainebupivacaine mixture 60 mL total, 30 mL per side or the standard care consisting of a 60 mL total dose of 0.2% ropivacaine administered via bilateral rectus sheath blocks along with bilateral catheters providing intermittent hourly boluses of ropivacaine 10 mL per hour per side. These interventions are given at the end of surgery. During the study, participants will be monitored for block-related and catheter-related complications, postoperative nausea and vomiting, pain scores, opioid consumption, time to extubation, length of stay in the hospital and ICU, patient satisfaction, quality of recovery, and opioid use after discharge. These measures will be assessed up to two weeks after surgery to evaluate outcomes and resource use associated with each pain management approach.

CONDITIONS

Brief Title

Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	RSB LB/B	RSB/RSC Ropivacaine
What it is	A rectus sheath block performed with a combination of liposomal bupivacaine and bupivacaine, intended to provide prolonged analgesia following open abdominal vascular surgery.	A rectus sheath block using ropivacaine, with a catheter for intermittent post-operative ropivacaine boluses, aiming for continuous pain relief after surgery.
Role in trial	Investigational group evaluating whether liposomal bupivacaine/bupivacaine rectus sheath block reduces postoperative pain, opioid use, length of stay, and complications versus ropivacaine.	Active comparator group to evaluate effectiveness and safety of ropivacaine rectus sheath block and catheters in post-surgical pain management.
Primary use	Pain management after mid-abdominal vascular surgery, aiming to improve post-operative outcomes and reduce opioid consumption.	Standard clinical method for post-operative analgesia, aiming to reduce surgical pain and allow effective recovery and reduced opioid usage.
How it is given or performed	Combination of 1.3% liposomal bupivacaine with 0.25% bupivacaine and saline is injected as a rectus sheath block, divided equally on each side.	Rectus sheath block performed using ropivacaine, followed by intermittent post-operative boluses via a catheter placed within the muscle sheath.
Evidence status	Liposomal bupivacaine is being investigated for its potential to provide longer post-operative analgesia after abdominal surgery. Multiple studies report mixed findings about its effectiveness in peripheral nerve blocks and abdominal procedures, with concerns noted about manufacturer financial conflicts of interest in published outcomes.	Ropivacaine rectus sheath block and catheter analgesia is supported by published evidence as a safe and effective method for post-operative pain control after laparotomy and major abdominal surgery.
Important limitations	Published reports note variability in analgesic effectiveness, with several studies showing inconsistent benefit compared to standard local anesthetics. Cost and potential for bias linked to manufacturer funding remain concerns.	Requires a catheter for ongoing bolus delivery, which can migrate or dislodge. Strict eligibility criteria exclude patients unable to receive repeated boluses or those with anatomical, infection, or weight-related contraindications.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 18 to 80 years
Scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision, including abdominal aortic aneurysm repair, mesenteric artery bypass, or aortobifemoral bypass
Able to speak and read English
American Society of Anesthesiology (ASA) physical status score I-IV
Hospitalized patients scheduled for the above surgeries at least three days after admission who are asymptomatic for vascular issues

You will not qualify if you...

Emergency vascular surgery due to symptoms like severe abdominal pain or ruptured aneurysm
Contraindications to rectus sheath blocks such as anatomical abnormalities, previous surgeries limiting block placement, or injection site infections
Allergy to local anesthetics
Weight less than 40 kg due to toxicity risk
Use of long-acting opioids or continuous opioid use over 50 MME per day for at least 30 days within 90 days before surgery
Chronic pain syndrome with recent preoperative chronic pain consultation or distant metastatic cancer
Current or recent (within 3 months) substance abuse including illicit drugs (except marijuana) or excessive alcohol use
Refusal or inability to sign consent
Inability to receive ropivacaine boluses postoperatively due to catheter issues
Planned additional abdominal wall surgery affecting pain or recovery outcomes

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to hospital discharge or up to 2 weeks

Participants receive a single-dose bilateral rectus sheath block with either liposomal bupivacaine/bupivacaine or ropivacaine. Those in the ropivacaine group also have catheters placed for intermittent hourly boluses.

Hospitalization period with monitoring visits during stay

Follow-up

Duration - Up to 2 weeks after discharge

Participants are monitored for postoperative recovery including pain, nausea, opioid use, complications, and quality of recovery up to 2 weeks after hospital discharge.

Visits at discharge and at 2 weeks after discharge