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RECRUITING
NCT05824338
EARLY_PHASE1

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

Sponsor: Fraser Health

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-08-27

Completion Date

2025-12-31

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

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.

Locations (2)

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Eagle Ridge Hospital

Port Moody, British Columbia, Canada