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

Study Overview
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Brief Summary
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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

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

Conditions
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Anesthesia, Spinal, Neurosurgery, Ropivacaine, Bupivacaine

Intervention / Treatment
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* Drug: Spinal anesthesia for lumbar surgery: ropivacaine
* Drug: Spinal anesthesia for lumbar surgery: bupivacaine
* Drug: General anesthesia for lumbar surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia with endotracheal tube<br>Currently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation. | Drug: General anesthesia for lumbar surgery<br>* Patient will be intubated and ventilated under general anesthesia.<br>* Other names: General Anesthesia with Endotracheal intubation;|
| Active Comparator: Spinal anesthesia with bupivacaine<br>Participants in this group will undergo lower lumbar surgery under spinal anesthesia with bupivacaine 0.5% 10-15 mg with fentanyl 10-15 mcg. | Drug: Spinal anesthesia for lumbar surgery: bupivacaine<br>* The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.<br>* Other names: Bupivacaine in the spinal anesthesia for lower lumbar surgery;|
| Experimental: Spinal anesthesia with ropivacaine<br>Participants in this group will undergo lower lumbar surgery under spinal anesthesia with ropivacaine 0.5% 10-20 mg with fentanyl 10-15 mcg. | Drug: Spinal anesthesia for lumbar surgery: ropivacaine<br>* The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally<br>* Other names: Ropivacaine in the spinal anesthesia for lower lumbar surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability 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 | 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 | 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 | 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 | 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 | Study duration, until last patient has completed the study (average of 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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). | 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) | 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 | 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 | 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 | 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 | 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) | 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 | 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) | 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. | 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) | 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) | 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) | 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) | 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). | 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). | 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). | 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 | 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). | 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. | 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 | 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. | 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. | Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal, Lumbar surgery, Lower back, Anesthesia