Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age19-80
SponsorFraser Health
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Spinal anesthesia for lumbar surgery: ropivacaine
- Spinal anesthesia for lumbar surgery: bupivacaine
- General anesthesia for lumbar surgery
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov