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Hypobaric L5-S1 Spinal Anesthesia for Anesthesia

N/A
Recruiting
Led By Ki Jinn Chin, MBBS,MMed,FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the end of surgery and before the patient is transferred to pacu on the day of surgery.
Awards & highlights

Summary

Patients going through total hip or knee replacement (arthroplasty) have to be put under spinal anesthesia to prevent them from feeling any pain during surgery. Spinal anesthesia means having a small needle inserted between the bones of the lower lumbar spine (vertebrae). The choice of space used is decided by the anesthesiologist in charge of patient care. The space between these bones is often narrowed by arthritis or other age-related degenerative spine disease in patients having total hip or knee replacement surgery. The lowest L5-S1 (Lumbar 5- Sacral 1) space is the largest one and often least affected by arthritis, which makes it the easiest option. Despite this, it is not currently the most common space used for spinal anesthesia, because it is hard to find by palpation (feeling the bones through the skin), and because there is concern that local anesthetic will not always spread up high enough from this lowest space, which is needed for a successful spinal anesthesia. How far it spreads depends on the amount (dose) and density of local anesthetic given. There are two types of local anesthetic: one called isobaric, which has the same density as CSF (Cerebro-Spinal Fluid), and another called hypobaric, which has lower density than CSF. Isobaric local anesthetic spreads evenly throughout the CSF irrespective of patient positioning. However, a larger dose is required to achieve adequate anesthesia for surgery. Using larger doses, leads to a very long duration of sensory and motor block, far in excess of that required for surgical completion which leads to a slower recovery from anesthesia. Hypobaric local anesthetic, on the other hand, floats in CSF like oil on water. This allows anesthesiologists to use a smaller dose while still being sure that it will spread high enough to achieve adequate anesthesia for surgery. The smaller doses in turn allow for faster recovery of normal movement and feeling in the legs of patients after surgery. It has been observed that all of these dilemma can be solved by: 1. Using ultrasound imaging to find and mark the space, and 2. Injecting hypobaric local anesthetic. The goal of this observational study is to determine the success rate of spinal anesthesia with a lower dose of hypobaric bupivacaine injected into the L5-S1 space, when done on total hip or knee arthroplasty patients at Toronto Western Hospital.

Eligible Conditions
  • Anesthesia
  • Local Anesthesia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed before surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed before surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Most cranial dermatomal level of sensory anesthesia achieved before surgery
Rate of successful spinal anesthesia
Time to achieve complete motor block at hip, knee, ankle, and toes
+7 more
Secondary study objectives
Incidence of adverse effects after spinal anesthesia
Number of needle passes
Patient satisfaction with anesthesia care, based on 3-response question
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypobaric L5-S1 Spinal AnesthesiaExperimental Treatment1 Intervention
Will receive a dose of hypobaric (0.33%) bupivacaine, administered at the L5-S1 space.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine injection
2024
N/A
~70

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,150 Total Patients Enrolled
Ki Jinn Chin, MBBS,MMed,FRCPCPrincipal InvestigatorUHN
~37 spots leftby Mar 2025