Actively Recruiting
Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Led by Fraser Health · Updated on 2024-10-08
45
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Not Yet Recruiting
2
Eagle Ridge Hospital
Port Moody, British Columbia, Canada, V3H 3W9
Actively Recruiting
Research Team
M
Michelle Mozel, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here