Status:
ACTIVE_NOT_RECRUITING
Hypobaric L5-S1 Study
Lead Sponsor:
University Health Network, Toronto
Conditions:
Anesthesia
Anesthesia, Local
Eligibility:
All Genders
20+ years
Brief 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 ...
Detailed Description
Spinal anesthesia is the recommended type of anesthesia for total hip or knee arthroplasty, as it is associated with superior clinical outcomes compared to general anesthesia. However, many patients u...
Eligibility Criteria
Inclusion
- Patients undergoing elective unilateral total hip or knee arthroplasty under spinal anesthesia at TWH who are scheduled for inpatient overnight admission
- American Society of Anesthesiologists physical status class (ASA-PS) 1-3
- At least 20 years of age
Exclusion
- Refusal to participate
- Inability to communicate due to language barrier or cognitive impairment
- Height \> 200 cm
- Weight \>120 kg
- Body mass index (BMI) \>45 kg/m\^2
- Contraindication or allergy to amide-type local anesthetic
- Contraindication to spinal anesthesia at the L5-S1 space (e.g., infection at the injection site, existing coagulopathy, severe spinal stenosis at higher vertebral levels)
- Previous spinal surgery in the lumbosacral spine
- Spinal anesthesia performed in the operating room rather than the block room
- Spinal anesthesia that includes administration of intrathecal opioids (e.g., morphine, fentanyl)
- Pre-existing sensory or motor impairment in the lower extremities
- Inability to identify the L5-S1 space with ultrasonography
Key Trial Info
Start Date :
July 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06526156
Start Date
July 22 2024
End Date
December 31 2025
Last Update
November 20 2025
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8