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

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 Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Spinal; Neurosurgery; Ropivacaine; Bupivacaine
• Intervention / Treatment: Drug: General anesthesia for lumbar surgery; Drug: Spinal anesthesia for lumbar surgery: bupivacaine; Drug: Spinal anesthesia for lumbar surgery: ropivacaine

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Michelle Mozel, MSc.; Phone Number: 523414 604-520-4253; Email: michelle.mozel@fraserhealth.ca

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital
      • Contact: Michelle Mozel, MSc; Phone Number: 523414 604-520-4253; Email: michelle.mozel@fraserhealth.ca
      • Principal Investigator: Alan Tung, MD
    • Port Moody, British Columbia, Canada, V3H 3W9
      • Eagle Ridge Hospital
      • Contact: Michelle Mozel, MSc.; Phone Number: 523414 604-520-4253; Email: michelle.mozel@fraserhealth.ca
      • Principal Investigator: Alan Tung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia with endotracheal tube; 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; Patient will be intubated and ventilated under general anesthesia.; Other Names: General Anesthesia with Endotracheal intubation
Active Comparator: Spinal anesthesia with bupivacaine; 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; The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.; Other Names: Bupivacaine in the spinal anesthesia for lower lumbar surgery
Experimental: Spinal anesthesia with ropivacaine; 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; The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally; Other Names: Ropivacaine in the spinal anesthesia for lower lumbar surgery

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing appropriateness of data collection intervals	Whether assessing the sensory and motor blocks by 10 to 20 minutes after spinal anesthesia is long enough to determine whether the spinal anesthesia dose has achieved a minimum sensory level to dermatomal level between T10 and T6 to ice and pinprick. We will thus be monitoring the time it takes to achieve this level (measured in minutes) as noted above.	Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Incidence of complications from spinal anesthesia: anemia	Drop in hemoglobin will be measured as a percentage in hemoglobin drop, as calculated by the preoperative hemoglobin minus the postoperative hemoglobin on postoperative day 1, then divided by the preoperative hemoglobin	Intraoperative and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Incidence of intraoperative complications from spinal anesthesia	Aggregate of complications (percentage of patients) who had issues during surgery (estimated blood loss (millilitres), incidence of low blood pressure (mean arterial pressure less than 65), incidence of low heart rate (less than 55), incidence of interventions to treat low blood pressure and/or low heart rate)	Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Incidence of postoperative complications from spinal anesthesia	Incidence of common side effects at 24 hours after surgery from spinal anesthesia or general anesthesia, including headache, nausea, vomiting, pruritus, dizziness, blurred vision, urinary retention, numbness or tingling in the upper extremities, sore throat, as well as any other side effects not mentioned	Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Incidence of other postoperative complications	Incidence of complications after surgery and up to discharge from hospital (headache after surgery, delirium or confusion, urinary retention requiring a Foley bladder catheter, need to return to the operating room for emergency re-operation, spinal hematoma, worsening nerve injury).	Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Incidence of other postoperative complications: neurological symptoms	Worsening in neurological symptoms at 24 hours after surgery	Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)

Collaborators and Investigators

• Sponsor: Fraser Health
• Investigators: Principal Investigator: Alan Tung, MD, Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Anesthesia; Spinal; Lumbar surgery; Lower back
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 2022430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No