Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

Обзор

The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to: * Determine the rates of eligibility, recruitment, consent, and attrition * Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia * Gather preliminary data on outcomes relevant to a future dose-finding study Participants will be randomized to one of three treatment groups: * General anesthesia with endotracheal tube * Spinal anesthesia with bupivacaine * Spinal anesthesia with ropivacaine

Вмешательства

• Препарат Spinal anesthesia for lumbar surgery: ropivacaine
  The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
• Препарат Spinal anesthesia for lumbar surgery: bupivacaine
  The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
• Препарат General anesthesia for lumbar surgery
  Patient will be intubated and ventilated under general anesthesia.

Первичные конечные точки

• Acceptability of study procedures and intervention: eligibility and recruitment [Срок оценки: Study duration, until last patient has completed the study (average of 1 year)]
• Acceptability of study procedures and intervention: attrition [Срок оценки: Study duration, until last patient has completed the study (average of 1 year)]
• Acceptability of study procedures and intervention: attrition (reasons) [Срок оценки: Study duration, until last patient has completed the study (average of 1 year)]
• Determining the success of our randomization procedures: as per protocol [Срок оценки: Study duration, until last patient has completed the study (average of 1 year)]
• Determining the success of our randomization procedures: randomization process [Срок оценки: Study duration, until last patient has completed the study (average of 1 year)]

Вторичные конечные точки (12)

• Preliminary outcome data: height of sensory block after intrathecal administration of study medications [Срок оценки: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: density of sensory block after intrathecal administration of study medications [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: motor block after intrathecal administration of study medications [Срок оценки: Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: pain scores [Срок оценки: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: total dosages of analgesics and sedatives ( [Срок оценки: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: hypotension [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: bradycardia [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: vasopressor requirements [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: completion rate [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: surgery abandonment rate [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: time [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
• Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique, and reasons [Срок оценки: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]

Критерии участия

Критерии включения

• Adult patients who are equal to or greater than 18 years old
• Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)
• Expected surgery duration of no greater than 2 hours
• ASA Physical Status Class 1 to 3
• Patient can have either spinal anesthesia or general anesthesia
• Able to provide consent and understand information in English, and capable of answering questions in English

Критерии исключения

• Allergy to either ropivacaine, bupivacaine, or local anesthetics
• Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)
• Surgery is expected to take more than 2 hours
• Emergency surgery
• Previously had back surgery at the level of the spine currently being operated on
• Comorbidities that require the patient to undergo general anesthesia
• Inability to stay still during the surgery
• Inability to move legs preoperatively
• Body Mass Index (BMI) >35
• Multilevel severe spinal stenosis

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

Открытое

Основная цель

Другое

Центры проведения

Канада · 2 центра

• Royal Columbian Hospital — New Westminster
• Eagle Ridge Hospital — Port Moody

Идентификаторы

NCT: NCT05824338 · 2022430

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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