Clinical trial NCT05824338: Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Official title: Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Anesthesia, Spinal
Neurosurgery
Ropivacaine
Bupivacaine
Keywords: Anesthesia
Spinal
Lumbar surgery
Lower back
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Acceptability of study procedures and intervention: eligibility and recruitment
timeFrame: Study duration, until last patient has completed the study (average of 1 year)
measure: Acceptability of study procedures and intervention: attrition
timeFrame: Study duration, until last patient has completed the study (average of 1 year)
measure: Acceptability of study procedures and intervention: attrition (reasons)
timeFrame: Study duration, until last patient has completed the study (average of 1 year)
measure: Determining the success of our randomization procedures: as per protocol
timeFrame: Study duration, until last patient has completed the study (average of 1 year)
measure: Determining the success of our randomization procedures: randomization process
timeFrame: Study duration, until last patient has completed the study (average of 1 year)
Secondary outcomes:
measure: Preliminary outcome data: height of sensory block after intrathecal administration of study medications
timeFrame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: density of sensory block after intrathecal administration of study medications
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: motor block after intrathecal administration of study medications
timeFrame: Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: pain scores
timeFrame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: total dosages of analgesics and sedatives (
timeFrame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: hypotension
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: bradycardia
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: vasopressor requirements
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: completion rate
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: surgery abandonment rate
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: time
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique, and reasons
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: operating room nurses' experience with conducting neurosurgery under neuraxial technique
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: operating room nurses' workload experience with conducting neurosurgery under neuraxial technique
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: postanesthetic care unit (PACU) nurses' experience
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: postanesthetic care unit (PACU) nurses' workload experience with conducting neurosurgery under neuraxial technique
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: number of attempts for the anesthesiologist to administer intrathecal medications
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: anesthesiologist's workload when conducting neurosurgery under spinal anesthesia
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's experience during spinal anesthesia administration
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's comfort during surgery
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's memory during surgery
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's discomfort with numbness or weakness postoperatively
timeFrame: Postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's preference preoperatively
timeFrame: Preoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Preliminary outcome data: patient's Quality of Recovery (QoR-15)
timeFrame: Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
Other outcomes:
measure: Assessing appropriateness of data collection intervals
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Incidence of complications from spinal anesthesia: anemia
timeFrame: Intraoperative and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Incidence of intraoperative complications from spinal anesthesia
timeFrame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Incidence of postoperative complications from spinal anesthesia
timeFrame: Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Incidence of other postoperative complications
timeFrame: Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
measure: Incidence of other postoperative complications: neurological symptoms
timeFrame: Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Port Moody
country: Canada
facility: Eagle Ridge Hospital
state: British Columbia
Study officials:
affiliation: Anesthesiologist
name: Alan Tung, MD
role: PRINCIPAL_INVESTIGATOR
References: