Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05824338
Other study ID # 2022430
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 1, 2024
Est. completion date April 30, 2024

Study information

Verified date November 2023
Source Fraser Health
Contact Michelle Mozel, MSc.
Phone 604-520-4253
Email michelle.mozel@fraserhealth.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Spinal anesthesia for lumbar surgery: ropivacaine
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Spinal anesthesia for lumbar surgery: bupivacaine
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
General anesthesia for lumbar surgery
Patient will be intubated and ventilated under general anesthesia.

Locations

Country Name City State
Canada Royal Columbian Hospital New Westminster British Columbia
Canada Eagle Ridge Hospital Port Moody British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Other 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 Intraoperative and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Other 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) Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Other 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 Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Other Incidence of other postoperative complications Incidence of complications after surgery and up to discharge from hospital (headache after surgery, delirium or confusion, urinary retention requiring a Foley bladder catheter, need to return to the operating room for emergency re-operation, spinal hematoma, worsening nerve injury). Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Other Incidence of other postoperative complications: neurological symptoms Worsening in neurological symptoms at 24 hours after surgery Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Primary 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 Study duration, until last patient has completed the study (average of 1 year)
Primary 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 Study duration, until last patient has completed the study (average of 1 year)
Primary 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 Study duration, until last patient has completed the study (average of 1 year)
Primary 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 Study duration, until last patient has completed the study (average of 1 year)
Primary Determining the success of our randomization procedures: randomization process Similarity of the groups on their baseline characteristics based on the demographic information Study duration, until last patient has completed the study (average of 1 year)
Secondary 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). Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary 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 Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary 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). Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary 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) Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: total dosages of analgesics and sedatives ( Total dosage of opioids and other analgesics (i.e., acetaminophen, NSAIDs) administered to the participant during surgery, and over 24 hours after surgery, as measured using milligrams Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: hypotension total duration of time (in minutes) with mean arterial pressure (MAP) below 65 Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: bradycardia total duration of time (in minutes) with heart rate below 55 Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: vasopressor requirements total dose of vasopressors used intraoperatively, as measured in milligrams Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: completion rate Percentage of participants in the spinal anesthesia group who successfully complete their lower back surgery without additional interventions (including conversion from spinal anesthesia to general anesthesia, additional analgesics through the intravenous line, additional spinal anesthesia medication dose given by the neurosurgeon, additional numbing medication infiltrated in the surgical incision by the neurosurgeon) Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: surgery abandonment rate by the number of patients who had spinal anesthesia who then had to be converted to general anesthesia or not complete surgery Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: time As measured in minutes, the time it takes to: from entering the operating room to the receiving the general anesthesia or spinal anesthesia medication, to the participant being in surgical position (lying on his/her stomach), to achieve sensory level of dermatomal level between T10 and T6 (numbness to ice and pinprick) Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique, and reasons Whether the neurosurgeon found operating on the spine to be more or less challenging under spinal anesthesia, in comparison to his or her previous experience with general anesthesia. This will be measured on a 5-point Likert scale, from "significantly less challenging" to "significantly more challenging". Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: neurosurgeon's experience with conducting neurosurgery under neuraxial technique Whether the neurosurgeons would recommend doing lumbar spine surgery under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely") Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: operating room nurses' experience with conducting neurosurgery under neuraxial technique Whether the operating room nurses would recommend doing lumbar spine surgery under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely") Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: operating room nurses' workload experience with conducting neurosurgery under neuraxial technique Operating room nurses' workload when helping with a spine surgery conducted under spinal anesthesia, compare to when helping with a spine surgery done under general anesthesia. . This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)" Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: postanesthetic care unit (PACU) nurses' experience Whether the PACU nurses would recommend having lumbar spine surgery done under spinal anesthesia as a feasible anesthetic option, measured on a 5-point Likert scale (from "very likely" to "very unlikely") Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: postanesthetic care unit (PACU) nurses' workload experience with conducting neurosurgery under neuraxial technique Postanesthetic care unit nurse (PACU) nurses' workload when taking care of a patient post-operatively from a spine surgery done under spinal anesthesia, compared to if the spine surgery had been done under general anesthesia. This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)". Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: number of attempts for the anesthesiologist to administer intrathecal medications Graded as 1 attempt, 2 attempts, =3 attempts, abandoned attempt, or no attempt made (i.e. general anesthesia). Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: anesthesiologist's workload when conducting neurosurgery under spinal anesthesia Anesthesiologists' workload when doing the spine surgery under spinal anesthesia, in comparison to general anesthesia. This would be measured on a 5-point Likert scale, from "significantly less work (compared to GA)" to "significantly more work (compared to GA)". Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's experience during spinal anesthesia administration Patients' experience during the administration of spinal anesthesia (inserting a needle into the back) in terms of pain tolerability. This will be assessed using the numerical rating scale (NRS). The NRS is a clinically used, validated scoring system ranging from 0 (no pain) to 10 (severe, excruciating pain Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's comfort during surgery Patients' comfort during the surgery if they received a spinal anesthetic. This will be assessed using the NRS (described above). There will also be 2 other options to choose from in case the patient is unable to report the pain level using the numerical rating scale (NRS), including "Patient does not remember", and "N/A (patient was in general anesthesia group)". Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's memory during surgery Whether patients who had spinal anesthesia remembered what happened during surgery. There will be 2 options: "Yes, I remember", and "No, I do not remember". Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's discomfort with numbness or weakness postoperatively For patients who had spinal anesthesia, they are asked whether they were bothered by the weakness and/or numbness in the legs in the PACU Postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's preference preoperatively The patients are asked if, prior to surgery, they had a preference for general anesthesia or spinal anesthesia. There will be three options: "I would prefer general anesthesia", "I would prefer spinal anesthesia", and "I have no preference". Preoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Secondary Preliminary outcome data: patient's Quality of Recovery (QoR-15) QoR-15 (Quality of Recovery) score, done 24 hours after surgery, covers a range of items including ease of breathing, enjoyment of food, feeling rested, sleep quality, able to do personal hygiene unaided, communication with friends and family, able to return to work and usual home activities, feeling of being in control, overall general well-being, pain levels, nausea or vomiting, anxiety, and depression. It is scored out of 150, with a higher score signifying better quality of recovery. Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
See also
  Status Clinical Trial Phase
Completed NCT03324984 - 1% Chloroprocaine(PF) vs. Bupivacaine Spinals Phase 2
Recruiting NCT03399019 - Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia N/A
Suspended NCT03967288 - Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery Phase 4
Completed NCT03316352 - Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients N/A
Completed NCT04092478 - '' Abdominal Crunch Positions With the Others in Terms of Interspinous Distance in Adult Patients ''
Recruiting NCT04128410 - A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
Completed NCT02961842 - Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery N/A
Completed NCT04050059 - Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. N/A
Completed NCT02833376 - Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis N/A
Not yet recruiting NCT06427382 - Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
Completed NCT03105115 - Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion N/A
Terminated NCT04996420 - Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty N/A
Not yet recruiting NCT06418308 - Intrathecal Dexmedetomidine vs Epinephrine Phase 4
Not yet recruiting NCT03142880 - Spinal Marginally Hyperbaric Ropivacaine for Cesarean Delivery N/A
Completed NCT03929874 - Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia
Completed NCT05379777 - Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia Phase 4
Completed NCT03959644 - Failure Rate in Spinal Blocks and Determination of Related Factors
Recruiting NCT03497364 - Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors N/A
Completed NCT03075488 - Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients N/A
Completed NCT06375863 - QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia N/A