Spinal anesthesia for lumbar surgery: ropivacaineSpinal anesthesia for lumbar surgery: bupivacaineGeneral anesthesia for lumbar surgery
Spinal anesthesia for lumbar surgery: ropivacaine: The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Spinal anesthesia for lumbar surgery: bupivacaine: The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
General anesthesia for lumbar surgery: Patient will be intubated and ventilated under general anesthesia.
Study summary
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
Eligibility
Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Acceptability of study procedures and intervention: eligibility and recruitment — Study duration, until last patient has completed the study (average of 1 year) Number of patients contacted who accepted or declined to participate in the study, with the acceptance rate calculated as the percentage of contacted patients who agreed to participate in the study
Acceptability of study procedures and intervention: attrition — Study duration, until last patient has completed the study (average of 1 year) Number of patients who complete the study after randomization, with the completion rate calculated as the percentage of randomized patients in whom we were able to collect the Quality of Recovery-15 survey results
Acceptability of study procedures and intervention: attrition (reasons) — Study duration, until last patient has completed the study (average of 1 year) Reasons why the patient, neurosurgeon and/or anesthesiologist refused to proceed with the patient's pilot study participation
Determining the success of our randomization procedures: as per protocol — Study duration, until last patient has completed the study (average of 1 year) Number of participants who actually get the intervention assigned to them, calculated as the percentage of randomized patients who receive the anesthetic protocol assigned to them
Determining the success of our randomization procedures: randomization process — Study duration, until last patient has completed the study (average of 1 year) Similarity of the groups on their baseline characteristics based on the demographic information
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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