Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age19-80
SponsorFraser Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Spinal anesthesia for lumbar surgery: ropivacaine
DrugThe anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Spinal anesthesia for lumbar surgery: bupivacaine
DrugThe anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
General anesthesia for lumbar surgery
DrugPatient will be intubated and ventilated under general anesthesia.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: General anesthesia with endotracheal tubeActive comparator 1 intervention
Group B: Spinal anesthesia with bupivacaineActive comparator 1 intervention
Group C: Spinal anesthesia with ropivacaineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of study procedures and intervention: eligibility and recruitment
Number of patients contacted who accepted or declined to participate in the study, with the acceptance rate calculated as the percentage of contacted patients who agreed to participate in the study
Time frame
Study duration, until last patient has completed the study (average of 1 year)2
Acceptability of study procedures and intervention: attrition
Number of patients who complete the study after randomization, with the completion rate calculated as the percentage of randomized patients in whom we were able to collect the Quality of Recovery-15 survey results
Time frame
Study duration, until last patient has completed the study (average of 1 year)3
Acceptability of study procedures and intervention: attrition (reasons)
Reasons why the patient, neurosurgeon and/or anesthesiologist refused to proceed with the patient's pilot study participation
Time frame
Study duration, until last patient has completed the study (average of 1 year)4
Determining the success of our randomization procedures: as per protocol
Number of participants who actually get the intervention assigned to them, calculated as the percentage of randomized patients who receive the anesthetic protocol assigned to them
Time frame
Study duration, until last patient has completed the study (average of 1 year)Secondary outcomes
1
Preliminary outcome data: height of sensory block after intrathecal administration of study medications
Assessing for dermatome level at which the patient has normal sensation to ice and pinprick, at specific intervals (every 2 minutes after spinal anesthesia up to 10 minutes or until thoracic level between T10 and T6 is achieved (whichever is later); on arrival to PACU; every 30 minutes after arrival to PACU until discharge to the ward or home).
Time frame
Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)2
Preliminary outcome data: density of sensory block after intrathecal administration of study medications
whether the patient is able to sense nothing, touch, or pain at time of first incision
Time frame
Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)3
Preliminary outcome data: motor block after intrathecal administration of study medications
assess for muscle strength at specific intervals (every 5 minutes up to 10 to 20 minutes after spinal anesthesia, on arrival to PACU (postanesthetic recovery unit), and every 30 minutes after arrival to PACU until discharge to the ward or home).
Time frame
Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)4
Preliminary outcome data: pain scores
preoperatively; intraoperatively; on arrival to PACU (postanesthetic recovery unit); at discharge from PACU to the ward or home; 24 hours after surgery. Measure: numerical rating scale (0 to 10, with 10 being excruciating pain)
Time frame
Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)Other outcomes
1
Assessing appropriateness of data collection intervals
Whether assessing the sensory and motor blocks by 10 to 20 minutes after spinal anesthesia is long enough to determine whether the spinal anesthesia dose has achieved a minimum sensory level to dermatomal level between T10 and T6 to ice and pinprick. We will thus be monitoring the time it takes to achieve this level (measured in minutes) as noted above.
Time frame
Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)2
Incidence of complications from spinal anesthesia: anemia
Drop in hemoglobin will be measured as a percentage in hemoglobin drop, as calculated by the preoperative hemoglobin minus the postoperative hemoglobin on postoperative day 1, then divided by the preoperative hemoglobin
Time frame
Intraoperative and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)3
Incidence of intraoperative complications from spinal anesthesia
Aggregate of complications (percentage of patients) who had issues during surgery (estimated blood loss (millilitres), incidence of low blood pressure (mean arterial pressure less than 65), incidence of low heart rate (less than 55), incidence of interventions to treat low blood pressure and/or low heart rate)
Time frame
Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)4
Incidence of postoperative complications from spinal anesthesia
Incidence of common side effects at 24 hours after surgery from spinal anesthesia or general anesthesia, including headache, nausea, vomiting, pruritus, dizziness, blurred vision, urinary retention, numbness or tingling in the upper extremities, sore throat, as well as any other side effects not mentioned
Time frame
Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)Sponsors and contacts
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Source ClinicalTrials.gov