Using ropivacaine for spinal anesthesia in lower back surgery
Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
This study is testing if using ropivacaine for spinal anesthesia during lower back surgery is a good option compared to general anesthesia and another spinal anesthesia drug.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Fraser Health Academic / other |
| Locations | 2 sites (New Westminster, British Columbia and 1 other locations) |
| Trial ID | NCT05824338 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to assess the feasibility of conducting a larger randomized controlled trial on the use of ropivacaine for spinal anesthesia in patients undergoing elective lower spine surgery. The study will evaluate eligibility rates, recruitment, consent, and attrition, as well as the acceptability of spinal anesthesia among patients and healthcare providers. Participants will be randomly assigned to receive either general anesthesia, spinal anesthesia with bupivacaine, or spinal anesthesia with ropivacaine. Preliminary data on relevant outcomes will also be collected to inform future studies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective one or two-level lumbar surgery.
Not a fit: Patients with allergies to ropivacaine or bupivacaine, or those with contraindications to spinal anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and recovery outcomes for patients undergoing lower back surgery.
How similar studies have performed: While the specific use of ropivacaine in this context is novel, similar studies on spinal anesthesia have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Westminster, British Columbia and 1 other locations
- Royal Columbian Hospital — New Westminster, British Columbia, Canada (Not_yet_recruiting)
- Eagle Ridge Hospital — Port Moody, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Alan Tung, MD — Anesthesiologist
- Study coordinator: Michelle Mozel, MSc.
- Email: michelle.mozel@fraserhealth.ca
- Phone: 604-520-4253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.