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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Liposomal bupivacaine
  Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
• Препарат Ropivacaine
  Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
• Препарат Bupivacain
  Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Первичные конечные точки

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

Вторичные конечные точки (10)

• Postoperative pain scores. [Срок оценки: Intensive Care Unit time duration and up to 96 postoperative hours]
• The time to extubation [Срок оценки: 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 [Срок оценки: During hospitalization up to 7 post-operative days]
• Hospital and Intensive Care Unit (ICU) length of stay (LOS) [Срок оценки: From the date and time of admission to the date and time of discharge, up to 2 weeks.]
• Hospital readmission and ED visits [Срок оценки: up to 2 weeks after discharge]
• Quality of Recovery-40 Questionnaire [Срок оценки: On postop day 4, at 2 weeks after discharge]
• Patient satisfaction with pain management using CSAT [Срок оценки: At discharge and at 2 weeks after the discharge, up to 96 postoperative hours]
• The time to the first rescue opioid. [Срок оценки: Up to 96 postoperative hour]
• The time to first postop antiemetics [Срок оценки: Up to 96 postoperative hour]
• Opioid use and refills within 2 weeks after hospital discharge [Срок оценки: Up to 2 weeks after discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Hartford Hospital — Hartford

Публикации

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• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25480622

Идентификаторы

NCT: NCT05972018 · HHC-2023-0134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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