Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery

Официальное название

Comparing Multifidus Cervicis Plane Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery

Обзор

The goal of this randomized, double-blinded, clinical trial is to assess the benefit of administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of postoperative pain control in patients undergoing posterior cervical spine fusion surgery. The main question it aims to answer is if the MCP block group will have reduced maximum pain scores during the first 24 postoperative hours compared to the sham block group. Participants will receive preoperative bilateral MCP blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mLs 0.25% Bupivacaine + 0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 mL Epinephrine (MCP block group). Researchers will compare the MCP block to the preoperative sham block which consists of injecting 3 mL of normal saline into the same area (Sham block group) to compare the postoperative pain scores between the groups as a main objective. The secondary objectives are: * Postoperative opioid consumption during hospitalization and at 2 weeks after discharge. * The amount and type of non-opioid analgesics used during hospitalization. * The occurrence of postoperative nausea and vomiting (PONV) and the use of antiemetics. * Hospital and Post Anesthesia Care Unit length of stay (LOS). * Monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge. * Patient satisfaction with pain management and overall satisfaction with the surgery experience.

Вмешательства

• Препарат Bupivacaine Hcl 0.25% Inj
  30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.
• Другое Normal saline
  3 mL normal saline

Первичные конечные точки

• The maximum postoperative pain score [Срок оценки: Up to 24 hours after surgery]

Вторичные конечные точки (8)

• The maximum, average, minimum, and current pain scores [Срок оценки: 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.]
• Total opioid consumption [Срок оценки: at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.]
• Non- opioid analgesics use [Срок оценки: Up to 72 hours postoperative]
• Postoperative nausea/vomiting scores [Срок оценки: Daily at 24th, 48th, and 72th postoperative hours]
• Hospital and Post Anesthesia Care Unit length of stay [Срок оценки: Up to 72 postoperative hours]
• The occurrence of block complications [Срок оценки: Up to 72 postoperative hours]
• Participant satisfaction with the pain management service and the overall surgery experience [Срок оценки: at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call]
• Antiemetics used [Срок оценки: up to 72 postoperative hours]

Критерии участия

Критерии включения

• Patients 40-80 years old, males and females, of any race and any ethnic group.
• Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
• Ability to speak and read English
• Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Критерии исключения

• Emergency posterior CSFS.
• Revision surgery or history of previous cervical spine surgery
• History of allergy to local anesthetics or steroids.
• Patients who are coagulopathic at the time of surgery
• Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks
• Infection at the site of the block.
• Weight < 40 kg to avoid local anesthetic toxicity.
• Patients on chronic or continuous opioid use of > 50 MME (morphine milli-equivalent) per day for at least 30 days within 90 days prior to surgery.
• Patients with a history of chronic inflammatory conditions such as multiple sclerosis
• Refusal to participate 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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Hartford Hospital — Hartford

Публикации

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. PMID 28403427
• Tseng V, Cole C, Schmidt MH, Abramowicz AE, Xu JL. Analgesic efficacy of paraspinal interfascial plane blocks performed with the use of neurophysiology monitoring for posterior cervical laminectomy surgery: a case series. J Spine Surg. 2021 Mar;7(1):109-113. doi: 10.21037/jss-20-644. PMID 33834133
• Youssef JA, Heiner AD, Montgomery JR, Tender GC, Lorio MP, Morreale JM, Phillips FM. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis. Spine J. 2019 Oct;19(10):1714-1729. doi: 10.1016/j.spinee.2019.04.019. Epub 2019 May 7. PMID 31075361
• Raja A, Patel P, Mesfin FB. Spinal Stenosis(Archived). 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/ PMID 28723018
• Ohgoshi Y, Kurahashi K. Cervical interfascial plane (CIP) block and multifidus cervicis plane (MCP) block: Similarities and tips. J Clin Anesth. 2017 Sep;41:55. doi: 10.1016/j.jclinane.2017.06.014. Epub 2017 Jun 27. No abstract available. PMID 28802607
• Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available. PMID 29433034
• Mohamed, Z.E., Zarad, C.A., Flifel, M.E. et al. The efficacy of ultrasound-guided multifidus cervicis plane block versus greater occipital nerve block for cervicogenic headache. Egypt J Neurol Psychiatry Neurosurg 57, 11 (2021). https://doi.org/10.1186/s41983-020-00262-4
• Adamczyk K, Koszela K, Zaczynski A, Niedzwiecki M, Brzozowska-Mankowska S, Gasik R. Ultrasound-Guided Blocks for Spine Surgery: Part 1-Cervix. Int J Environ Res Public Health. 2023 Jan 23;20(3):2098. doi: 10.3390/ijerph20032098. PMID 36767465

Идентификаторы

NCT: NCT05996133 · HHC-2023-0156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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