Spinal anesthesia for lumbar surgery: ropivacaine
DrugThe anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Other names: Ropivacaine in the spinal anesthesia for lower lumbar surgery
NCT Number: NCT05824338
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
Interested in participating?
Request Info19 year–80 year
All sexes
Interventional
Early Phase 1
Royal Columbian Hospital, New Westminster, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally
Other names: Ropivacaine in the spinal anesthesia for lower lumbar surgery
The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.
Other names: Bupivacaine in the spinal anesthesia for lower lumbar surgery
Patient will be intubated and ventilated under general anesthesia.
Other names: General Anesthesia with Endotracheal intubation
Time frame: Study duration, until last patient has completed the study (average of 1 year)
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)
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)
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)
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)
Similarity of the groups on their baseline characteristics based on the demographic information
Time frame: Intraoperative and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
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 (per patient); study duration after last patient has completed the study (average of 1 year)
whether the patient is able to sense nothing, touch, or pain at time of first incision
Time frame: Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)
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 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
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)
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
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
total duration of time (in minutes) with mean arterial pressure (MAP) below 65
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
total duration of time (in minutes) with heart rate below 55
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
total dose of vasopressors used intraoperatively, as measured in milligrams
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
by the number of patients who had spinal anesthesia who then had to be converted to general anesthesia or not complete surgery
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)"
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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")
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
Graded as 1 attempt, 2 attempts, ≥3 attempts, abandoned attempt, or no attempt made (i.e. general anesthesia).
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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)".
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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".
Time frame: Postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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
Time frame: Preoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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".
Time frame: Postoperative (per patient); study duration after last patient has completed the study (24 hours after surgery) (average of 1 year)
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.
Time frame: Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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 and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)
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 (per patient); study duration after last patient has completed the study (average of 1 year)
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: Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
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)
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).
Time frame: Postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)
Worsening in neurological symptoms at 24 hours after surgery
Contact information is provided by the study sponsor or research team.
Fraser Health
Other
Acronym: SASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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