Pilot Study Testing Spinal Anesthesia with Ropivacaine Compared to Bupivacaine and General Anesthesia for Lower Back Surgery

What this Trial Is About

Researchers are evaluating the use of ropivacaine in spinal anesthesia for patients undergoing elective 1- or 2-level lower lumbar spine surgery. This pilot clinical trial aims to test the feasibility of conducting a randomized controlled trial by examining eligibility, recruitment, consent, attrition rates, and the acceptability of spinal anesthesia among patients and medical staff. The study will gather preliminary data relevant to future dose-finding studies. Participants will be randomly assigned to one of three groups general anesthesia with endotracheal intubation, spinal anesthesia with bupivacaine 0.5% plus fentanyl, or spinal anesthesia with ropivacaine 0.5% plus fentanyl. The spinal anesthesia groups will receive specific doses of local anesthetics intrathecally before their lower lumbar surgery. During the study, participants will be monitored intraoperatively and postoperatively up to 24 hours for outcomes like sensory and motor block heights, pain scores, anesthesiologist and nurse experiences, patient comfort, and adverse events such as hypotension or bradycardia. Researchers will assess the acceptability of study procedures, randomization success, and reasons for attrition over approximately one year until the last patient completes the study.

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