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

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fraser Health
• Treatments: Anesthetics; Bupivacaine; Ropivacaine

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