A Phase 4 interventional study of Liposomal bupivacaine and Ropivacaine in Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion and Aortoiliac Occlusive Disease, sponsored by Hartford Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Hartford Hospital · Phase 4, Interventional, and Supportive care
The goal of this pilot study is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will assess the safety and feasibility of this approach compared to standard of care.
Participants will receive either a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for differences in the rate of postoperative complications, resources consumed with each intervention, as well as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery, and hospital length of stay.
Exclusion Criteria:
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
Drug: Liposomal bupivacaine · Drug: Bupivacain
Rectus Sheath Block: Total 60mL of 0.2% ropivacaine (3 vials) (30mL per side) \+ Rectus Sheath Catheter intermittent hourly boluses of 0.2% ropivacaine 10mL/hr per side
Drug: Ropivacaine
Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
Also known as: Exparel
Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
Also known as: Naropin
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)
Also known as: Bupivacaine HCL
The cost of care during hospitalization.
To compare the resources consumed by each intervention from many different perspectives (e.g. anesthesia staff cost per time spent to perform the study intervention and the successive daily evaluations, facility cost per length of stay, block and catheter medication cost, block and catheter supply cost.)
Time frame: From the time of the blocks until the date of discharge, assessed as 2 weeks
The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week.
Determine whether patients receiving ropivacaine in rectus sheath catheter versus Bupivacaine/Liposomal Bupivacaine in rectus sheath block have any difference in the occurrence of any related complications or adverse events up to hospital discharge or up to one week.
Time frame: From the date of the block until the date of discharge, assessed up to 1 week
Postoperative nausea and vomiting
Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale will be used daily through the duration of in-hospital care (1-7 days)
Time frame: Up to 96 postoperative hours
Postoperative pain scores.
The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants, daily and up to the end of the 96 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
Time frame: Intensive Care Unit time duration and up to 96 postoperative hours
The time to extubation
The time to extubation: from anesthesia end time to the time of removing the endotracheal tube in the Intensive Care Unit.
Time frame: From anesthesia end date and time to the date and time of extubation, assessed up to 96 postoperative hours
Intraop, postop, and total opioid consumption
The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.
Time frame: During hospitalization up to 7 post-operative days
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
Determine whether patients receiving ropivacaine in RSC versus B/LB in RSB have any the difference in the duration of ICU stay, in addition to the duration of hospitalization if \> or \< 7 days.
Time frame: From the date and time of admission to the date and time of discharge, up to 2 weeks.
Hospital readmission and ED visits
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
Time frame: up to 2 weeks after discharge
Quality of Recovery-40 Questionnaire
Determine any differences between the two groups in the quality of recovery using the "Quality of Recovery Questionnaire-40 questionnaire" which consists of 40 questions categorized into 5 dimensions; emotional state (9 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (5 questions), and pain (7 questions). All questions scored from 1-5; positive items are scored from 1 (worst) to 5 (best); whereas scores are reversed for negative items 1 (best) to 5 (worst).
Time frame: On postop day 4, at 2 weeks after discharge
Patient satisfaction with pain management using CSAT
Patient satisfaction with pain management after surgery using the CSAT score: 5 very satisfied, 4 satisfied, 3 neutral, 2 unsatisfied, 1 very unsatisfied. this assessment on the day of discharge (estimated 168 postoperative hours) and at 2 weeks after discharge, via a phone call.
Time frame: At discharge and at 2 weeks after the discharge, up to 96 postoperative hours
The time to the first rescue opioid.
The time from the last intraoperative opioid given to the time of the first rescue opioid given after surgery is measured in hours.
Time frame: Up to 96 postoperative hour
The time to first postop antiemetics
The time from the last intraoperative antiemetic medication given to the time of the first rescue antiemetic medication given after surgery is measured in hours.
Time frame: Up to 96 postoperative hour
Opioid use and refills within 2 weeks after hospital discharge
Opioid use and refills within 2 weeks after hospital discharge (yes or no)
Time frame: Up to 2 weeks after discharge
Plan to share: No
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Hartford Hospital