NCT05824338

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anesthesia, Spinal
• Neurosurgery
• Ropivacaine
• Bupivacaine

Interventions

Type	Name	Description
DRUG	Spinal anesthesia for lumbar surgery: ropivacaine	The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
DRUG	Spinal anesthesia for lumbar surgery: bupivacaine	The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
DRUG	General anesthesia for lumbar surgery	Patient will be intubated and ventilated under general anesthesia.

Timeline

• Start date: 2024-08-27
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2023-04-21
• Last updated: 2024-10-08

Locations

2 sites across 1 country: Canada