AzTrials
AzTrials

Aortic Aneurysm, AbdominalPhase 4EXODUSNCT05972018

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

A Phase 4 study testing Liposomal bupivacaine, Ropivacaine and Bupivacain in people with Aortic Aneurysm, Abdominal and Abdominal Aortic Occlusion, run by Hartford Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Liposomal bupivacaine, Ropivacaine and Bupivacain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
18 Oct 2023to 30 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Hartford Hospital

    Hartford, Connecticut, 06102

    Kevin J Finkel, MD, kevin.finkel@hhchealth.org

    Aseel Walker, MD, 860-9772-1778, Aseel.Walker@hhchealth.org

    Recruiting

Other trials in United States

About this study

Official title: Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks And Catheters With Intermittent Hourly Boluses.

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.

Being tested
Liposomal bupivacaine, Ropivacaine, Bupivacain
Keywords
Open abdominal aortic repair surgery, Rectus Sheath Block, Rectus Sheath Block and Catheter, Liposomal Bupivacaine, Exparel, Ropivacaine continuous infusion
Medical subject headings
Aortic Aneurysm, Abdominal, Aortic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal bupivacaineDrug

    Also called Exparel

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

  • RopivacaineDrug

    Also called Naropin

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

  • BupivacainDrug

    Also called Bupivacaine HCL

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

Study groups in NCT05972018
Study groupRoleWhat they receive
RSB LB/BExperimentalRectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
Receives: Drug: Liposomal bupivacaine; Drug: Bupivacain
RSB/RSC RopivacaineActive comparatorRectus 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
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: From the time of the blocks until the date of discharge, assessed as 2 weeks

  2. 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.

    Measured: From the date of the block until the date of discharge, assessed up to 1 week

  3. 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)

    Measured: Up to 96 postoperative hours

Secondary outcomes (10)
  1. 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.

    Measured: Intensive Care Unit time duration and up to 96 postoperative hours

  2. 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.

    Measured: From anesthesia end date and time to the date and time of extubation, assessed up to 96 postoperative hours

  3. Intraop, postop, and total opioid consumption

    The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.

    Measured: During hospitalization up to 7 post-operative days

  4. 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.

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

  5. Hospital readmission and ED visits

    Incidences of hospital readmission and emergency visits within 2 weeks after discharge

    Measured: up to 2 weeks after discharge

  6. 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).

    Measured: On postop day 4, at 2 weeks after discharge

  7. 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.

    Measured: At discharge and at 2 weeks after the discharge, up to 96 postoperative hours

  8. 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.

    Measured: Up to 96 postoperative hour

  9. 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.

    Measured: Up to 96 postoperative hour

  10. Opioid use and refills within 2 weeks after hospital discharge

    Opioid use and refills within 2 weeks after hospital discharge (yes or no)

    Measured: Up to 2 weeks after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start18 Oct 2023
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A prospective, single-center, open-label, interventional pilot study
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05972018
Sponsor's protocol ID
HHC-2023-0134
Acronym
EXODUS
Status last verified
Mar 2025
First submitted
17 Jul 2023
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burger JW, van 't Riet M, Jeekel J. Abdominal incisions: techniques and postoperative complications. Scand J Surg. 2002;91(4):315-21. doi: 10.1177/145749690209100401.

    PubMed 12558078
  • Kenna P, Melekamayhu A. Bilateral rectus sheath block as postoperative analgesia for patients undergoing midline laparotomy in Minilk II Referral Hospital, Addis Ababa, Ethiopia. [master's thesis]. Addis Ababa, Ethiopia: Addis Ababa University; 2018.doi.org/10.4103%2F0259-1162.179315

  • Weissman C. Pulmonary function after cardiac and thoracic surgery. Anesth Analg. 1999 Jun;88(6):1272-9. doi: 10.1097/00000539-199906000-00014. No abstract available.

    PubMed 10357329
  • Agostini P, Calvert R, Subramanian H, Naidu B. Is incentive spirometry effective following thoracic surgery? Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):297-300. doi: 10.1510/icvts.2007.171025. Epub 2007 Nov 26.

    PubMed 18039692
  • Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.

    PubMed 30833861
  • Purdy M, Kinnunen M, Kokki M, Anttila M, Eskelinen M, Hautajarvi H, Lehtonen M, Kokki H. A prospective, randomized, open label, controlled study investigating the efficiency and safety of 3 different methods of rectus sheath block analgesia following midline laparotomy. Medicine (Baltimore). 2018 Feb;97(7):e9968. doi: 10.1097/MD.0000000000009968.

    PubMed 29443788
  • Wallstrom A, Frisman GH. Facilitating early recovery of bowel motility after colorectal surgery: a systematic review. J Clin Nurs. 2014 Jan;23(1-2):24-44. doi: 10.1111/jocn.12258. Epub 2013 Jun 20.

    PubMed 23786567
  • Alvarez MP, Foley KE, Zebley DM, Fassler SA. Comprehensive enhanced recovery pathway significantly reduces postoperative length of stay and opioid usage in elective laparoscopic colectomy. Surg Endosc. 2015 Sep;29(9):2506-11. doi: 10.1007/s00464-014-4006-8. Epub 2014 Dec 6.

    PubMed 25480622
  • Atkinson CJ, Ramaswamy K, Stoneham MD. Regional anesthesia for vascular surgery. Semin Cardiothorac Vasc Anesth. 2013 Jun;17(2):92-104. doi: 10.1177/1089253212472985. Epub 2013 Jan 17.

    PubMed 23327951
  • Hong S, Kim H, Park J. Analgesic effectiveness of rectus sheath block during open gastrectomy: A prospective double-blinded randomized controlled clinical trial. Medicine (Baltimore). 2019 Apr;98(15):e15159. doi: 10.1097/MD.0000000000015159.

    PubMed 30985694
  • Hausken J, Rydenfelt K, Horneland R, Ullensvang K, Kjosen G, Tonnessen TI, Haugaa H. First Experience With Rectus Sheath Block for Postoperative Analgesia After Pancreas Transplant: A Retrospective Observational Study. Transplant Proc. 2019 Mar;51(2):479-484. doi: 10.1016/j.transproceed.2019.01.065. Epub 2019 Jan 28.

    PubMed 30879572
  • Patzkowski MS, Stevens G. Multimodal analgesia in abdominal sepsis: a case report of liposome bupivacaine in ultrasound-guided rectus sheath blocks after unexpected open hemi-colectomy. Mil Med. 2015 Jun;180(6):e728-31. doi: 10.7205/MILMED-D-14-00512.

    PubMed 26032393
  • Urits I, Ostling PS, Novitch MB, Burns JC, Charipova K, Gress KL, Kaye RJ, Eng MR, Cornett EM, Kaye AD. Truncal regional nerve blocks in clinical anesthesia practice. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):559-571. doi: 10.1016/j.bpa.2019.07.013. Epub 2019 Jul 19.

    PubMed 31791571
  • Cho S, Kim YJ, Jeong K, Moon HS. Ultrasound-guided bilateral rectus sheath block reduces early postoperative pain after laparoscopic gynecologic surgery: a randomized study. J Anesth. 2018 Apr;32(2):189-197. doi: 10.1007/s00540-018-2457-0. Epub 2018 Feb 8.

    PubMed 29423579
  • Jeong HW, Kim CS, Choi KT, Jeong SM, Kim DH, Lee JH. Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief after Laparoscopic Cholecystectomy: A Randomized Controlled Study. J Clin Med. 2019 Jul 11;8(7):1018. doi: 10.3390/jcm8071018.

    PubMed 31336767

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal bupivacaine, Ropivacaine and Bupivacain in people with Aortic Aneurysm, Abdominal and Abdominal Aortic Occlusion, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aseel Walker, MD ((860) 972-1778, aseel.walker@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05972018, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in