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

Ropivacaine | Anesthesia, Spinal | Bupivacaine | Neurosurgery

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

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    19 to 80

Critères de participation

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 approach in 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 of answering questions in English

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, high intracranial 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

Lieu de l'étude

Eagle Ridge Hospital
Eagle Ridge Hospital
Port Moody, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Michelle Mozel, MSc.

[email protected]
604-520-4253
Royal Columbian Hospital
Royal Columbian Hospital
New Westminster, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Michelle Mozel, MSc

[email protected]
604-520-4253
Étude parrainée par
Fraser Health
Participants recherchés
Plus d'informations
ID de l'étude: NCT05824338