Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
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
Timeline
- Start
- 2024-08-27
- Primary completion
- 2025-07-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.5 % | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 3 ml | Intrathecal |
| Subject | Ropivacaine | Other / unclassified | 0.5 % | Intrathecal |
| Subject | Ropivacaine | Other / unclassified | 4 ml | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | 15 ug | Intrathecal |
Indications
No indication recorded.