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.
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
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion, Aortoiliac Occlusive Disease
- 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
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Kevin J Finkel, MD, kevin.finkel@hhchealth.org
Aseel Walker, MD, 860-9772-1778, Aseel.Walker@hhchealth.org
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.
- Conditions
- Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion, Aortoiliac Occlusive Disease, Aortic Diseases
- 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 group | Role | What they receive |
|---|---|---|
| RSB LB/B | Experimental | Rectus 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 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 Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
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
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
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.
Hospital readmission and ED visits
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
- First posted2 Aug 2023
- Study start18 Oct 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Finkel, Hartford Hospital
- Investigators
- Kevin Finkel, MD, Principal investigator, Hartford Hospital
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 12558078Kenna 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 10357329Agostini 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 18039692Simpson 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 30833861Purdy 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 29443788Wallstrom 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 23786567Alvarez 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 25480622Atkinson 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 23327951Hong 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 30985694Hausken 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 30879572Patzkowski 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 26032393Urits 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 31791571Cho 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 29423579Jeong 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05972018
- Acronym / sponsor ID
- EXODUS / HHC-2023-0134
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, single-center, open-label, interventional pilot study
| Arm | Type | Receives |
|---|---|---|
| RSB LB/B | Experimental | Drug: Liposomal bupivacaine, Drug: BupivacainRectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side) |
| RSB/RSC Ropivacaine | Active comparator | Drug: RopivacaineRectus 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelRectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side) | Drug | RSB LB/B |
| RopivacaineAlso: NaropinTotal 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials) | Drug | RSB/RSC Ropivacaine |
| BupivacainAlso: Bupivacaine HCLRectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side) | Drug | RSB LB/B |
Primary outcome
The cost of care during hospitalization.
Time frame: From the time of the blocks until the date of discharge, assessed as 2 weeks
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.)
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
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.
Postoperative nausea and vomiting
Time frame: Up to 96 postoperative hours
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)
10 secondary outcomes
Postoperative pain scores.
Time frame: Intensive Care Unit time duration and up to 96 postoperative hours
The time to extubation
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
Time frame: During hospitalization up to 7 post-operative days
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
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
Time frame: up to 2 weeks after discharge
Quality of Recovery-40 Questionnaire
Time frame: On postop day 4, at 2 weeks after discharge
Patient satisfaction with pain management using CSAT
Time frame: At discharge and at 2 weeks after the discharge, up to 96 postoperative hours
The time to the first rescue opioid.
Time frame: Up to 96 postoperative hour
The time to first postop antiemetics
Time frame: Up to 96 postoperative hour
Opioid use and refills within 2 weeks after hospital discharge
Time frame: Up to 2 weeks after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 12558078Burger 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.
- BackgroundKenna 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
- Background: PubMed 10357329Weissman 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.
- Background: PubMed 18039692Agostini 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.
- Background: PubMed 30833861Simpson 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.
- Background: PubMed 29443788Purdy 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.
- Background: PubMed 23786567Wallstrom 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.
- Background: PubMed 25480622Alvarez 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.
- Background: PubMed 23327951Atkinson 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.
- Background: PubMed 30985694Hong 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.
- Background: PubMed 30879572Hausken 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.
- Background: PubMed 26032393Patzkowski 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.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Finkel, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
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.