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

Last updated: October 4, 2024
Sponsor: Fraser Health
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

General anesthesia for lumbar surgery

Spinal anesthesia for lumbar surgery: bupivacaine

Spinal anesthesia for lumbar surgery: ropivacaine

Clinical Study ID

NCT05824338
2022430
  • Ages 19-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patients who are equal to or greater than 18 years old

  • Undergoing elective one or two-level lumbar surgery via posterior surgical approachin the prone position (between L2-S1)

  • Expected surgery duration of no greater than 2 hours

  • ASA Physical Status Class 1 to 3

  • Patient can have either spinal anesthesia or general anesthesia

  • Able to provide consent and understand information in English, and capable ofanswering questions in English

Exclusion

Exclusion Criteria:

  • Allergy to either ropivacaine, bupivacaine, or local anesthetics

  • Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants,severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, highintracranial pressure, infection at the puncture site)

  • Surgery is expected to take more than 2 hours

  • Emergency surgery

  • Previously had back surgery at the level of the spine currently being operated on

  • Comorbidities that require the patient to undergo general anesthesia

  • Inability to stay still during the surgery

  • Inability to move legs preoperatively

  • Body Mass Index (BMI) >35

  • Multilevel severe spinal stenosis

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: General anesthesia for lumbar surgery
Phase: 1
Study Start date:
August 27, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Royal Columbian Hospital

    New Westminster, British Columbia V3L 3W7
    Canada

    Site Not Available

  • Eagle Ridge Hospital

    Port Moody, British Columbia V3H 3W9
    Canada

    Active - Recruiting

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