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Recruiting NCT05824338

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

Early Phase I Interventional Anesthesia, Spinal Neurosurgery Ropivacaine Bupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal anesthesia for lumbar surgery: ropivacaine, Spinal anesthesia for lumbar surgery: bupivacaine, General anesthesia for lumbar surgery.
Who it may be relevant to
Registry conditions: Anesthesia, Spinal, Neurosurgery, Ropivacaine, Bupivacaine. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Primary outcome measures

  • Acceptability of study procedures and intervention: eligibility and recruitment [Time frame: Study duration, until last patient has completed the study (average of 1 year)]
  • Acceptability of study procedures and intervention: attrition [Time frame: Study duration, until last patient has completed the study (average of 1 year)]
  • Acceptability of study procedures and intervention: attrition (reasons) [Time frame: Study duration, until last patient has completed the study (average of 1 year)]
  • Determining the success of our randomization procedures: as per protocol [Time frame: Study duration, until last patient has completed the study (average of 1 year)]
  • Determining the success of our randomization procedures: randomization process [Time frame: Study duration, until last patient has completed the study (average of 1 year)]
Secondary outcome measures (12)
  • Preliminary outcome data: height of sensory block after intrathecal administration of study medications [Time frame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: density of sensory block after intrathecal administration of study medications [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: motor block after intrathecal administration of study medications [Time frame: Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: pain scores [Time frame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: total dosages of analgesics and sedatives ( [Time frame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: hypotension [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: bradycardia [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: vasopressor requirements [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: completion rate [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: surgery abandonment rate [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: time [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]
  • Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique, and reasons [Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Canada · 2 centers
  • Royal Columbian Hospital — New Westminster
  • Eagle Ridge Hospital — Port Moody

Identifiers

NCT: NCT05824338 · 2022430

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗