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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
45
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
Patient will be intubated and ventilated under general anesthesia.
Royal Columbian Hospital
New Westminster, British Columbia, Canada
NOT_YET_RECRUITINGEagle Ridge Hospital
Port Moody, British Columbia, Canada
RECRUITINGAcceptability of study procedures and intervention: eligibility and recruitment
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
Time frame: Study duration, until last patient has completed the study (average of 1 year)
Acceptability of study procedures and intervention: attrition
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
Time frame: Study duration, until last patient has completed the study (average of 1 year)
Acceptability of study procedures and intervention: attrition (reasons)
Reasons why the patient, neurosurgeon and/or anesthesiologist refused to proceed with the patient's pilot study participation
Time frame: Study duration, until last patient has completed the study (average of 1 year)
Determining the success of our randomization procedures: as per protocol
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
Time frame: Study duration, until last patient has completed the study (average of 1 year)
Determining the success of our randomization procedures: randomization process
Similarity of the groups on their baseline characteristics based on the demographic information
Time frame: Study duration, until last patient has completed the study (average of 1 year)
Preliminary outcome data: height of sensory block after intrathecal administration of study medications
Assessing for dermatome level at which the patient has normal sensation to ice and pinprick, at specific intervals (every 2 minutes after spinal anesthesia up to 10 minutes or until thoracic level between T10 and T6 is achieved (whichever is later); on arrival to PACU; every 30 minutes after arrival to PACU until discharge to the ward or home).
Time frame: 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
whether the patient is able to sense nothing, touch, or pain at time of first incision
Time frame: 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
assess for muscle strength at specific intervals (every 5 minutes up to 10 to 20 minutes after spinal anesthesia, on arrival to PACU (postanesthetic recovery unit), and every 30 minutes after arrival to PACU until discharge to the ward or home).
Time frame: 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
preoperatively; intraoperatively; on arrival to PACU (postanesthetic recovery unit); at discharge from PACU to the ward or home; 24 hours after surgery. Measure: numerical rating scale (0 to 10, with 10 being excruciating pain)
Time frame: 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 (
Total dosage of opioids and other analgesics (i.e., acetaminophen, NSAIDs) administered to the participant during surgery, and over 24 hours after surgery, as measured using milligrams
Time frame: 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
total duration of time (in minutes) with mean arterial pressure (MAP) below 65
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: bradycardia
total duration of time (in minutes) with heart rate below 55
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: vasopressor requirements
total dose of vasopressors used intraoperatively, as measured in milligrams
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: completion rate
Percentage of participants in the spinal anesthesia group who successfully complete their lower back surgery without additional interventions (including conversion from spinal anesthesia to general anesthesia, additional analgesics through the intravenous line, additional spinal anesthesia medication dose given by the neurosurgeon, additional numbing medication infiltrated in the surgical incision by the neurosurgeon)
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: surgery abandonment rate
by the number of patients who had spinal anesthesia who then had to be converted to general anesthesia or not complete surgery
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: time
As measured in minutes, the time it takes to: from entering the operating room to the receiving the general anesthesia or spinal anesthesia medication, to the participant being in surgical position (lying on his/her stomach), to achieve sensory level of dermatomal level between T10 and T6 (numbness to ice and pinprick)
Time frame: 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
Whether the neurosurgeon found operating on the spine to be more or less challenging under spinal anesthesia, in comparison to his or her previous experience with general anesthesia. This will be measured on a 5-point Likert scale, from "significantly less challenging" to "significantly more challenging".
Time frame: 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
Whether the neurosurgeons would recommend doing lumbar spine surgery under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: operating room nurses' experience with conducting neurosurgery under neuraxial technique
Whether the operating room nurses would recommend doing lumbar spine surgery under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: operating room nurses' workload experience with conducting neurosurgery under neuraxial technique
Operating room nurses' workload when helping with a spine surgery conducted under spinal anesthesia, compare to when helping with a spine surgery done under general anesthesia. . This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)"
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: postanesthetic care unit (PACU) nurses' experience
Whether the PACU nurses would recommend having lumbar spine surgery done under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: postanesthetic care unit (PACU) nurses' workload experience with conducting neurosurgery under neuraxial technique
Postanesthetic care unit nurse (PACU) nurses' workload when taking care of a patient post-operatively from a spine surgery done under spinal anesthesia, compared to if the spine surgery had been done under general anesthesia. This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: number of attempts for the anesthesiologist to administer intrathecal medications
Graded as 1 attempt, 2 attempts, ≥3 attempts, abandoned attempt, or no attempt made (i.e. general anesthesia).
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: anesthesiologist's workload when conducting neurosurgery under spinal anesthesia
Anesthesiologists' workload when doing the spine surgery under spinal anesthesia, in comparison to general anesthesia. This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's experience during spinal anesthesia administration
Patients' experience during the administration of spinal anesthesia (inserting a needle into the back) in terms of pain tolerability. This will be assessed using the numerical rating scale (NRS). The NRS is a clinically used, validated scoring system ranging from 0 (no pain) to 10 (severe, excruciating pain
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's comfort during surgery
Patients' comfort during the surgery if they received a spinal anesthetic. This will be assessed using the NRS (described above). There will also be 2 other options to choose from in case the patient is unable to report the pain level using the numerical rating scale (NRS), including "Patient does not remember", and "N/A (patient was in general anesthesia group)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's memory during surgery
Whether patients who had spinal anesthesia remembered what happened during surgery. There will be 2 options: "Yes, I remember", and "No, I do not remember".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's discomfort with numbness or weakness postoperatively
For patients who had spinal anesthesia, they are asked whether they were bothered by the weakness and/or numbness in the legs in the PACU
Time frame: Postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's preference preoperatively
The patients are asked if, prior to surgery, they had a preference for general anesthesia or spinal anesthesia. There will be three options: "I would prefer general anesthesia", "I would prefer spinal anesthesia", and "I have no preference".
Time frame: Preoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: patient's Quality of Recovery (QoR-15)
QoR-15 (Quality of Recovery) score, done 24 hours after surgery, covers a range of items including ease of breathing, enjoyment of food, feeling rested, sleep quality, able to do personal hygiene unaided, communication with friends and family, able to return to work and usual home activities, feeling of being in control, overall general well-being, pain levels, nausea or vomiting, anxiety, and depression. It is scored out of 150, with a higher score signifying better quality of recovery.
Time frame: Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
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