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

2022430

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

2024-01-01

2024-04-30

2024-04-30

Not yet recruiting

Early phase I

45

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2023-11-14