Anesthesia, SpinalEarly Phase 1SASSNCT05824338
Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
A Early Phase 1 study testing Spinal anesthesia for lumbar surgery: ropivacaine, Spinal anesthesia for lumbar surgery: bupivacaine and General anesthesia for lumbar surgery in people with Anesthesia, Spinal and Neurosurgery, run by Fraser Health at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Anesthesia, Spinal, Neurosurgery, Ropivacaine
- What is being tested?
- Spinal anesthesia for lumbar surgery: ropivacaine, Spinal anesthesia for lumbar surgery: bupivacaine and General anesthesia for lumbar surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Aug 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Inability to stay still during the surgery
- Inability to move legs preoperatively
- Body Mass Index (BMI) >35
- Multilevel severe spinal stenosis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Michelle Mozel, MSc, 604-520-4253 ext. 523414, michelle.mozel@fraserhealth.ca
Alan Tung, MD
- Recruiting
Eagle Ridge Hospital
Port Moody, British Columbia, V3H 3W9
Michelle Mozel, MSc., 604-520-4253 ext. 523414, michelle.mozel@fraserhealth.ca
Alan Tung, MD
About this study
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
Read more
Participants will be randomized to one of three treatment groups:
- General anesthesia with endotracheal tube
- Spinal anesthesia with bupivacaine
- Spinal anesthesia with ropivacaine
- Conditions
- Anesthesia, Spinal, Neurosurgery, Ropivacaine, Bupivacaine
- Being tested
- Spinal anesthesia for lumbar surgery: ropivacaine, Spinal anesthesia for lumbar surgery: bupivacaine, General anesthesia for lumbar surgery
- Keywords
- Anesthesia, Spinal, Lumbar surgery, Lower back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia for lumbar surgery: ropivacaineDrug
Also called Ropivacaine in the spinal anesthesia for lower lumbar surgery
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Spinal anesthesia for lumbar surgery: bupivacaineDrug
Also called Bupivacaine in the spinal anesthesia for lower lumbar surgery
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
General anesthesia for lumbar surgeryDrug
Also called General Anesthesia with Endotracheal intubation
Patient will be intubated and ventilated under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with endotracheal tube | Active comparator | Currently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation. Receives: Drug: General anesthesia for lumbar surgery |
| Spinal anesthesia with bupivacaine | Active comparator | Participants in this group will undergo lower lumbar surgery under spinal anesthesia with bupivacaine 0.5% 10-15 mg with fentanyl 10-15 mcg. Receives: Drug: Spinal anesthesia for lumbar surgery: bupivacaine |
| Spinal anesthesia with ropivacaine | Experimental | Participants in this group will undergo lower lumbar surgery under spinal anesthesia with ropivacaine 0.5% 10-20 mg with fentanyl 10-15 mcg. Receives: Drug: Spinal anesthesia for lumbar surgery: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Study duration, until last patient has completed the study (average of 1 year)
Secondary outcomes (25)
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).
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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".
Measured: 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")
Measured: 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")
Measured: 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)"
Measured: 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")
Measured: 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)".
Measured: 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).
Measured: 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)".
Measured: 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
Measured: 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)".
Measured: 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".
Measured: 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
Measured: 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".
Measured: 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.
Measured: Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start27 Aug 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Tung, Fraser Health
- Investigators
- Alan Tung, MD, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824338
- Sponsor's protocol ID
- 2022430
- Acronym
- SASS
- Status last verified
- Oct 2024
- First submitted
- 9 Mar 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
- ClinicalTrials.gov ID
- NCT05824338
- Acronym / sponsor ID
- SASS / 2022430
- Conditions
- Anesthesia, Spinal, Neurosurgery, Ropivacaine, Bupivacaine
- Keywords
- Anesthesia, Spinal, Lumbar surgery, Lower back
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with endotracheal tube | Active comparator | Drug: General anesthesia for lumbar surgeryCurrently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation. |
| Spinal anesthesia with bupivacaine | Active comparator | Drug: Spinal anesthesia for lumbar surgery: bupivacaineParticipants in this group will undergo lower lumbar surgery under spinal anesthesia with bupivacaine 0.5% 10-15 mg with fentanyl 10-15 mcg. |
| Spinal anesthesia with ropivacaine | Experimental | Drug: Spinal anesthesia for lumbar surgery: ropivacaineParticipants in this group will undergo lower lumbar surgery under spinal anesthesia with ropivacaine 0.5% 10-20 mg with fentanyl 10-15 mcg. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia for lumbar surgery: ropivacaineAlso: Ropivacaine in the spinal anesthesia for lower lumbar surgeryThe anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally | Drug | Spinal anesthesia with ropivacaine |
| Spinal anesthesia for lumbar surgery: bupivacaineAlso: Bupivacaine in the spinal anesthesia for lower lumbar surgeryThe anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally. | Drug | Spinal anesthesia with bupivacaine |
| General anesthesia for lumbar surgeryAlso: General Anesthesia with Endotracheal intubationPatient will be intubated and ventilated under general anesthesia. | Drug | General anesthesia with endotracheal tube |
Primary outcome
Acceptability of study procedures and intervention: eligibility and recruitment
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
25 secondary outcomes
Preliminary outcome data: height of sensory block after intrathecal administration of study medications
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
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
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
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 (
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
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: bradycardia
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: vasopressor requirements
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: completion rate
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: surgery abandonment rate
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Preliminary outcome data: time
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
Time frame: Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Tung, MD principal investigator
Anesthesiologist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Spinal anesthesia for lumbar surgery: ropivacaine, Spinal anesthesia for lumbar surgery: bupivacaine and General anesthesia for lumbar surgery in people with Anesthesia, Spinal and Neurosurgery, run by Fraser Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Mozel, MSc. (604-520-4253 ext. 523414, michelle.mozel@fraserhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of study procedures and intervention: eligibility and recruitment (time frame: Study duration, until last patient has completed the study (average of 1 year)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.