RecruitingEarly Phase 1NCT05824338

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


Sponsor

Fraser Health

Enrollment

45 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study is exploring whether ropivacaine — a long-acting local anesthetic — can be safely and effectively used in spinal anesthesia for patients undergoing lower back (lumbar) surgery. Currently, most lumbar surgeries are performed under general anesthesia, which carries more risks and often results in longer recovery times. Spinal anesthesia, where a local anesthetic is injected into the fluid around the spinal cord to numb the lower body, can reduce the need for opioids and general anesthetics, and may enable faster recovery. Ropivacaine is a newer local anesthetic with a potentially longer duration and improved safety profile compared to older alternatives like bupivacaine. To be eligible, participants must be adults (19–80 years) undergoing elective one or two-level lumbar spine surgery (between L2 and S1) expected to take 2 hours or less, with an ASA status of I–III, who are able to receive either spinal or general anesthesia and communicate in English. Those with allergies to local anesthetics, contraindications to spinal anesthesia (such as blood clotting problems), very high BMI, prior surgery at the same level, or expected surgery longer than 2 hours are excluded. Participants receive spinal anesthesia with ropivacaine and are monitored for effectiveness, sensory block duration, recovery time, and pain control. This pilot study lays the groundwork for a larger trial that could eventually establish spinal anesthesia as a standard option for lumbar surgery, potentially improving patient experience and reducing opioid use after surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpinal anesthesia for lumbar surgery: ropivacaine

The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally

DRUGSpinal anesthesia for lumbar surgery: bupivacaine

The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.

DRUGGeneral 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

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NCT05824338


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