Comparing 3 approaches for spinal anesthesia
Official title: Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
- Early Phase 1
- 3 groups
- Sites in New Westminster and Port Moody
- Recruiting
Interventions
- Medication
Spinal anesthesia for lumbar surgery: ropivacaine
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
- Medication
Spinal anesthesia for lumbar surgery: bupivacaine
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
- Medication
General anesthesia for lumbar surgery
Patient will be intubated and ventilated under general anesthesia.
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Eagle Ridge Hospital
Port Moody, British Columbia
- Not yet recruiting
Royal Columbian Hospital
New Westminster, British Columbia
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +ASA Physical Status Class 1 to 3
- +Adult patients who are equal to or greater than 18 years old
- +Patient can have either spinal anesthesia or general anesthesia
- +Able to provide consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and understand information in English, and capable of answering questions in English
- +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
Exclusion
- −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 siteTrial siteA hospital or clinic where a study is actually run.Read more →)
- −Comorbidities that require the patient to undergo general anesthesia
- −Inability to move legs preoperatively
- −Body Mass Index (BMI) \>35
- −Multilevel severe spinal stenosis
- −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
- −Inability to stay still during the surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Early Phase 1Early Phase 1A very small, very early study of how the body handles a treatment.Read more → — the earliest human testing, in a very small group, to observe how the body handles it.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A, the comparison group, receives General anesthesia for lumbar surgery.
Registry label: A: General anesthesia with endotracheal tube
Group B, the comparison group, receives Spinal anesthesia for lumbar surgery: bupivacaine.
Registry label: B: Spinal anesthesia with bupivacaine
Group C receives Spinal anesthesia for lumbar surgery: ropivacaine.
Registry label: C: Spinal anesthesia with ropivacaine
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 19 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 45 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: Study duration, until last patient has completed the study (average of 1 year).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Acceptability of study procedures and intervention: eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → and recruitment — measured over Study duration, until last patient has completed the study (average of 1 year).
Acceptability of study procedures and intervention: attrition — measured over Study duration, until last patient has completed the study (average of 1 year).
Acceptability of study procedures and intervention: attrition (reasons) — measured over Study duration, until last patient has completed the study (average of 1 year).
Determining the success of our randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → procedures: as per protocolProtocolThe detailed plan a study must follow.Read more → — measured over Study duration, until last patient has completed the study (average of 1 year).
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05824338 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Spinal anesthesia for lumbar surgery: ropivacaineDrug
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Spinal anesthesia for lumbar surgery: bupivacaineDrug
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About General anesthesia for lumbar surgeryDrug
Patient will be intubated and ventilated under general anesthesia.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 19 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 19 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Study duration, until last patient has completed the study (average of 1 year).
The study as a whole is currently expected to finish around 2025-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 45 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: New Westminster, British Columbia, Canada; Port Moody, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.