Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
NCT Number: NCT06166394
The length of hospital stay after total hip and knee arthroplasty is determined based on the successful mobilization of the patients post surgery. Fast track pathways involving early mobilization and discharge of the patient on the same day of surgery, shortens the hospital stay and reduces the risk of adverse effects. The long acting LA (bupivacaine) is most commonly used in spinal anesthesia for arthroplasty surgeries and is associated with a prolonged motor and sensory block. In contrast, hypobaric bupivacaine and hypobaric mepivacaine helps in achieving the desired block level with smaller dosage and shorter onset time and faster recovery when compared to long acting local anesthetics. The aim of the study is to observe the effects of hypobaric local anesthetics ( bupivacaine and mepivacaine ) in patients undergoing unilateral total hip or knee arthroplasty in terms of time to onset and time to recovery of the block and also its effect on hemodynamic stability and time to mobilization after surgery. This study will allow the investigators to recommend optimal dosing strategies that in turn will help in faster recovery from spinal anesthesia and early mobilization thereby reducing harmful outcomes.
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Notify Me20 year and older
All sexes
Observational
Toronto, Ontario, M5T 2S8, Canada
Fast-track pathways involving same day mobilization and hospital discharge for total hip and knee arthroplasty are increasingly popular in modern orthopedic practice. Numerous reports have demonstrated the feasibility of this approach.
The choice of local anesthetic (LA) drug and dose administered in spinal anesthesia is determined by several considerations including the desired block height (the upper limit of sensory loss and surgical anesthesia that is achieved) and block duration. Block height and duration should be adequate for the surgery in question, but should ideally not be excessive, as they can lead to adverse effects including sympathetic blockade and hypotension, urinary retention, and delayed recovery of motor function in the lower limbs. The long-acting amide LA, bupivacaine, is most commonly used in this setting at Toronto Western Hospital (TWH) and elsewhere in the world. It is, however, associated with a prolonged motor and sensory recovery (4-6 hours). An alternative strategy to achieve adequate block height without using excessive doses of LA is to administer a hypobaric solution of bupivacaine or mepivacaine; this has been trialed with success at TWH and is now used routinely by staff anesthesiologists. Nevertheless, most of the investigator's knowledge regarding hypobaric LA solutions in spinal anesthesia comes from studies that are more than two decades old. There are no studies on mepivacaine, and neither hypobaric bupivacaine nor mepivacaine have been investigated in the context of fast-track total hip and knee arthroplasty pathways. In this context, the ideal LA solution used for spinal anesthesia should provide a consistent and fast onset time to achieve the required surgical anesthesia while the sensory and motor block should resolve as soon as possible after surgery. The investigators believe that hypobaric bupivacaine and hypobaric mepivacaine may satisfy these criteria and hence, the investigators aim to study their pharmacodynamics.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Other names: Carbocaine
Administration of a hypobaric spinal mixture for In-patients:
3ml of 0.33% bupivacaine created by 2ml 0.5% bupivacaine with 1ml sterile water
Other names: Marcaine
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Sensory block will be assessed every 5 mins during the first 30 mins after spinal injection. A pinprick test using an 18G (Gauge) blunt-tipped needle (BD Blunt Fill needle) will be performed on non-dependent and dependent sides to detect sensory loss over the torso and lower limbs.
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed over the duration of time period till the patient is discharged.
Will be assessed by the measurement of vitals
Time frame: Assessed over the duration of time period till the patient is discharged.
Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.
Time frame: Assessed before the patient is discharged.
Assessed by a five-point Likert scale provided to the patient
Time frame: Assessed after the end of surgery.
Assessed by a three-point Likert scale provided to the surgeon
Time frame: Assessed after the spinal block till the end of surgery
Will be determined as successful when there will be no need to convert to general anesthesia or administer supplemental opioids or local infiltration in the operating room.
University Health Network, Toronto
Other
Pharmacodynamic Profile of Intrathecal Hypobaric Local Anesthetics. An Observational Study
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