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Идёт набор NCT05029726

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Фаза IV С лечением Lumbar Spinal Stenosis Lumbar Disc Herniation Lumbar Spondylolisthesis Lumbar Spondylosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine, normal saline.
Кому может быть актуально
Состояния в реестре: Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spondylosis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery

Обзор

Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.

Подробное описание

Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.

Dependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.

Erector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.

The proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.

The investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.

Вмешательства

  • Препарат Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
    Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
  • Препарат normal saline
    normal saline in 30cc syringes administered using ESPB technique

Первичные конечные точки

  • Inpatient opioid consumption [Срок оценки: Every 1 day during inpatient admission up to 30 days]
Вторичные конечные точки (11)
  • Post-discharge opioid consumption [Срок оценки: 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively]
  • Postoperative opioid prescriptions filled [Срок оценки: From hospital discharge to 90 days postoperatively]
  • Length of hospital stay [Срок оценки: From time of surgery to time discharge criteria met in hours, up to 2160 hours]
  • Postoperative Urinary Retention (POUR) [Срок оценки: Immediately post-surgery to discharge, up to 90 days]
  • Post-operative delirium [Срок оценки: Immediately post-surgery to discharge]
  • Post-operative delirium [Срок оценки: Immediately post-surgery to discharge, up to 90 days]
  • Postoperative pain scores [Срок оценки: Every 1 day during inpatient admission up to 30 days]
  • Patient-reported pain and functional outcomes [Срок оценки: From baseline preoperative values to 6 week post-operative values]
  • Patient-reported pain and functional outcomes [Срок оценки: From baseline preoperative values to 6 week post-operative values]
  • Patient-reported pain and functional outcomes [Срок оценки: From baseline preoperative values to 6 week post-operative values]
  • Peri-operative complications [Срок оценки: Time of surgery to 6 weeks postoperative]

Критерии участия

Критерии включения

  • Age 18-80
  • Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
  • Willing and able to give consent

Критерии исключения

  • Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
  • Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
  • Known allergy to bupivacaine, clonidine or similar local anesthetics
  • Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
  • Chronic kidney disease (stage 3 or greater), or hepatic failure
  • Active pregnancy
  • Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period
  • Active Worker's Compensation litigation

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Rush University Medical Center — Chicago

Публикации

  • Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855. PMID 30180150
  • Chin KJ, Dinsmore MJ, Lewis S, Chan V. Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. Eur Spine J. 2020 Dec;29(Suppl 2):138-144. doi: 10.1007/s00586-019-06133-8. Epub 2019 Sep 3. PMID 31482311
  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PMID 27501016
  • Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27. PMID 29704223
  • Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603. PMID 31033625
  • Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15. PMID 30424594
  • van den Broek RJC, van de Geer R, Schepel NC, Liu WY, Bouwman RA, Versyck B. Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. Sci Rep. 2021 Apr 7;11(1):7631. doi: 10.1038/s41598-021-87374-w. PMID 33828209
  • Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30. doi: 10.1097/BRS.0000000000000622. PMID 25417827

Идентификаторы

NCT: NCT05029726 · ORA20050502

Первоисточники (государственные реестры)

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