Abdominal incisions: techniques and postoperative complications.
J W A Burger, M van 't Riet, J Jeekel
https://pubmed.ncbi.nlm.nih.gov/12558078Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID05972018
Liposomal Bupivacaine/Bupivacaine Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks and Catheters with Hourly Boluses for Vascular Surgery
Led by Hartford Hospital · Updated on 2025-09-03
14
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
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 bupivacaine/bupivacaine 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 bupivacaine/bupivacaine 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
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Research Team
A
Aseel Walker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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