Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

Launched by FRASER HEALTH · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of ropivacaine, a medication for pain relief, in spinal anesthesia for patients undergoing lower back surgery. The main goal is to see if it's possible to conduct a larger study that compares ropivacaine with another pain relief option, bupivacaine, as well as general anesthesia, which is when you are completely asleep during surgery. Researchers want to find out how many people are eligible and willing to participate, how well this type of anesthesia is accepted by everyone involved, and collect early information on how effective it might be.

To be eligible for this trial, participants need to be adults aged 18 or older who are having elective (planned) back surgery that involves one or two levels of the spine. They should be able to lie still during the procedure and understand information in English. However, people with certain medical conditions, allergies to the study medications, or those needing emergency surgery won't be able to take part. If you join the study, you’ll be randomly assigned to one of three groups: one will receive general anesthesia, another will receive spinal anesthesia with bupivacaine, and the last group will receive spinal anesthesia with ropivacaine. The trial is currently looking for volunteers, and your participation could help improve pain management options for future patients.

Gender

ALL

Eligibility 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