BridgeMD
New treatment option for Anesthesia, Spinal
Official title Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
ClinicalTrials.gov ID: NCT05824338
What this study is testing
What is Spinal anesthesia for lumbar surgery: ropivacaine?
Spinal anesthesia for lumbar surgery: ropivacaine is an investigational medicine, being studied as a potential treatment for anesthesia, spinal.
Also referred to as Ropivacaine in the spinal anesthesia for lower lumbar surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Westminster, British Columbia, Canada
- Port Moody, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Westminster, British Columbia, Canada; Port Moody, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.