Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

Официальное название

Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.

Обзор

This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.

Вмешательства

• Препарат Liposomal Bupivicaine/Bupivacaine Admixture
  60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL
• Препарат Bupivacaine HCL
  80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL

Первичные конечные точки

• The highest Numerical Pain Scores [Срок оценки: 3 days]

Вторичные конечные точки (9)

• The highest Numerical Pain Scores for the period of 0-47 hours [Срок оценки: up to 3 days]
• All pain scores, mild-moderate-severe. [Срок оценки: up to 72 postoperative hours]
• Postoperative opioid consumption measured in morphine MilliEquivalent (MME) [Срок оценки: Up to 6 days post surgery.]
• Postoperative nausea/vomiting scores [Срок оценки: 30 days]
• Hospital and post-anesthesia care unit length of stay [Срок оценки: 6 days]
• Duration of the study block using the sensory function test [Срок оценки: Pre-block intervention, immediately after surgery, up to 3 days]
• Brief Pain Inventory (Short Form) [Срок оценки: On the day of first postoperative visit, the end of the 6th and 12th postoperative months]
• Block complications [Срок оценки: Up to 30 postoperative days]
• Patient Overall Satisfaction [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
• English speaking patients
• Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Критерии исключения

• Emergency laparoscopic colectomy surgery
• Patients with distant metastatic cancers (e.g. bone, lung, brain).
• Scheduled for multi organs resection surgery in addition to colectomy.
• Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
• Current colostomies.
• History of allergy to local anesthetics.
• Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
• Weight < 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
• Patients who take long acting opioid medication, or on continuous opioid > 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
• Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 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.15
• Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
• Refusal or lack of providing the study consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hartford Hospital — Hartford

Публикации

• Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25. PMID 28742435
• Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29. PMID 20116145
• Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747. PMID 28059913
• Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4. PMID 31797098
• Smith SR, Draganic B, Pockney P, Holz P, Holmes R, Mcmanus B, Carroll R. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial. Int J Colorectal Dis. 2015 Sep;30(9):1237-45. doi: 10.1007/s00384-015-2286-7. Epub 2015 Jun 24. PMID 26099316
• Qazi N, Bhat WM, Iqbal MZ, Wani AR, Gurcoo SA, Rasool S. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial. Anesth Essays Res. 2017 Jul-Sep;11(3):767-772. doi: 10.4103/0259-1162.194577. PMID 28928585
• Erratum to highlighted version successful resection of a tracheal metastasis of rectal cancer: a case report. J Thorac Dis. 2017 Oct;9(10):E978. doi: 10.21037/jtd.2017.10.137. PMID 29266106
• Liu L, Xie YH, Zhang W, Chai XQ. Effect of Transversus Abdominis Plane Block on Postoperative Pain after Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials. Med Princ Pract. 2018;27(2):158-165. doi: 10.1159/000487323. Epub 2018 Feb 1. PMID 29402875

Идентификаторы

NCT: NCT05224089 · HHC-2021-0331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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