Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain

Официальное название

Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain

Обзор

Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone. A few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.

Подробное описание

Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers/perforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia.

Although an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. A common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. Over the last few decades the United States has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. An opioid free combination of Bupivacaine-Ketorolac-Ketamine (BKK) is thought to be effective in alleviating perioperative and postoperative pain.

Вмешательства

• Препарат Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
  The plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \[3 mg/mL\], Ketorolac Tromethamine 24 mg \[1.2mg/mL\], Ketamine HCl 24 mg \[1.2 mg/mL\]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \[5mg/ml\]. The dose can be repeated multiple times during the procedure as per operator's discretion. The patients will be further stratified into sub-groups based on type of procedure they had unde

Первичные конечные точки

• Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity [Срок оценки: Upto 1 week]
• Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort [Срок оценки: Upto 1 week]
• Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL) [Срок оценки: Upto 1 week]

Вторичные конечные точки (4)

• Hospital readmission rates [Срок оценки: Until 7 days (Until the end of the sutdy)]
• Adverse Effects [Срок оценки: Until 7 days (Until the end of the sutdy)]
• Cost comparison of medications [Срок оценки: Upto 1 week]
• Amount of pain medication used [Срок оценки: Upto 1 week]

Критерии участия

Критерии включения

• Both male and female patients
• Patients older than 18 years of age
• Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)
• Patients willing to participate in the study

Критерии исключения

• Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine
• Pregnant or breastfeeding patients
• Prisoners
• Patients younger than 18 years of age
• Patients not willing to participate in the study
• Patients deemed not suitable or unstable for the study as per physician's discretion

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Loma Linda University Health — Loma Linda
• Kansas City Heart Rhythm Institute — Overland Park
• Overland Park Regional Medical Center — Overland Park

Публикации

• Mariano ER, Dickerson DM, Szokol JW, Harned M, Mueller JT, Philip BK, Baratta JL, Gulur P, Robles J, Schroeder KM, Wyatt KEK, Schwalb JM, Schwenk ES, Wardhan R, Kim TS, Higdon KK, Krishnan DG, Shilling AM, Schwartz G, Wiechmann L, Doan LV, Elkassabany NM, Yang SC, Muse IO, Eloy JD, Mehta V, Shah S, Johnson RL, Englesbe MJ, Kallen A, Mukkamala SB, Walton A, Buvanendran A. A multisociety organizatio PMID 34552003
• De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29. PMID 21965355
• Wolfe RC, Spillars A. Local Anesthetic Systemic Toxicity: Reviewing Updates From the American Society of Regional Anesthesia and Pain Medicine Practice Advisory. J Perianesth Nurs. 2018 Dec;33(6):1000-1005. doi: 10.1016/j.jopan.2018.09.005. No abstract available. PMID 30449428
• Nair GM, Birnie DH, Sumner GL, Krahn AD, Healey JS, Nery PB, Kalfon E, Verma A, Ayala-Paredes F, Coutu B, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Sturmer M, Kavanagh K, Crystal E, Wells GA, Essebag V; BRUISE CONTROL Investigators. Post-operative pain following cardiac implantable electronic device implantation: insights from the BR PMID 33367623
• Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3. PMID 30983590
• Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097/00002508-200501000-00012. PMID 15599137

Идентификаторы

NCT: NCT05575999 · KCHRRF-PAINFREE POCKET-0016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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