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

NCT05972018 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HHC-2023-0134
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.)

  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.

  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)

  Up to 96 postoperative hours

Secondary Outcomes (10)

• Postoperative pain scores.

  Intensive Care Unit time duration and up to 96 postoperative hours

• The time to extubation

  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

  During hospitalization up to 7 post-operative days

• Hospital and Intensive Care Unit (ICU) length of stay (LOS)

  From the date and time of admission to the date and time of discharge, up to 2 weeks.

• Hospital readmission and ED visits

  up to 2 weeks after discharge

Study Arms (2)

RSB LB/B

EXPERIMENTAL

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

Drug: Liposomal bupivacaine; Drug: Bupivacain

RSB/RSC Ropivacaine

ACTIVE COMPARATOR

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

Interventions

Liposomal bupivacaine DRUG

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

Also known as: Exparel

RSB LB/B

Ropivacaine DRUG

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

Also known as: Naropin

RSB/RSC Ropivacaine

Bupivacain DRUG

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

Also known as: Bupivacaine HCL

RSB LB/B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• 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.
• Patients who are able to speak and read English
• Patients with American Society of Anesthesiology (ASA) physical status score I-IV
• 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.

You may not qualify if:

• 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.
• 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.
• History of allergy to local anesthetics.
• 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.
• 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.
• 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.
• 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.
• Lack or refusal to sign the study consent.
• 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.
• 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.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

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MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Diseases

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kevin Finkel, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aseel Walker, MD

CONTACT

(860) 972-1778; aseel.walker@hhchealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research - HH Department of Anesthesiology

Model Details: A prospective, single-center, open-label, interventional pilot study

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 2, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)