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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSB LB/B | Experimental | Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intensive Care Unit time duration and up to 96 postoperative hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aseel Walker, MD | Contact | (860) 972-1778 | aseel.walker@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Finkel, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12558078 | Background | 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. | |
| Background | 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 | ||
| 10357329 |
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A prospective, single-center, open-label, interventional pilot study
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| Ropivacaine | Drug | Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials) |
|
|
| Bupivacain | Drug | Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side) |
|
|
| 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. | 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. | 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. | 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 | 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). | 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. | 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. | 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. | 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) | Up to 2 weeks after discharge |
| Background |
| 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. |
| 18039692 | Background | 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. |
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| 23786567 | Background | 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. |
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| 30879572 | Background | 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. |
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| 31791571 | Background | 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. |
| 29423579 | Background | 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. |
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| Background | Sholin I.Y., Avetisyan V.A., Ezugbaia B.S., Zhikharev V.A., Koryachkin V.A. Assessment of rectus sheath block effectiveness after major abdominal surgery. Regionarnaya аnesteziya i lechenie ostroy boli (Regional Anesthesia and Acute Pain Management, Russian journal). 2018; 12 (1): 37-40 . (In Russ.). DOI: http://dx.doi.org/10.18821/1993-6508-2018-12-1- 37- 40. |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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