Recruiting

Bupivacaine vs. Ropivacaine

Sponsor:

Hartford Hospital

Code:

NCT05972018

Conditions

Aortic Aneurysm, Abdominal

Abdominal Aortic Occlusion

Aortoiliac Occlusive Disease

Aortic Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liposomal bupivacaine

Ropivacaine

Bupivacain

Study Details

Brief summary:

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.

Conditions

Aortic Aneurysm, Abdominal

Abdominal Aortic Occlusion

Aortoiliac Occlusive Disease

Aortic Diseases

Study ID

NCT05972018

Start date

Oct 18, 2023

Status verified date

Mar, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

14 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: RSB LB/B

Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)

active comparator: RSB/RSC Ropivacaine

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

Interventions

Liposomal bupivacaine

Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)

Ropivacaine

Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)

Bupivacain

Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Primary outcome measure

  • The cost of care during hospitalization. [ 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. [ Time Frame: From the date of the block until the date of discharge, assessed up to 1 week ]
  • Postoperative nausea and vomiting [ Time Frame: Up to 96 postoperative hours ]

Central Contacts and Locations

Central contacts

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

More Information

Sponsor

Hartford Hospital

Last update posted

Sep 3, 2025

Last verified

Mar, 2025

Keywords

  • Open abdominal aortic repair surgery
  • Rectus Sheath Block
  • Rectus Sheath Block and Catheter
  • Liposomal Bupivacaine
  • Exparel
  • Ropivacaine continuous infusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2025-09-03.