Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526156
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Hypobaric L5-S1 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Anesthetic and Recovery Profiles of Low-dose Hypobaric Bupivacaine in Spinal Anesthesia Injected in the L5-S1 Space for Total Hip and Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 undergoing these surgical procedures have age-related spine disease previous spine surgery or other spinal deformities which make the injection of spinal anesthesia difficult
One strategy is to administer the spinal anesthesia at the L5-S1 space it is least affected by arthritic and degenerative changes and as it is the largest intervertebral space it has the lowest chance of causing spinal cord trauma
However administration of spinal anesthesia at the lowest lumbar intervertebral levels significantly decreases the odds of success of surgical anesthesia This is due to the fact that the standard solution of 05 bupivacaine is isobaric with respect to the cerebrospinal fluid CSF leading to unpredictable distribution within the CSF and inconsistent extent of sensory block It has been shown that an inordinately large dose of 25 mg 5 milliliter of 05 bupivacaine is required to achieve the adequate extent of sensory loss as opposed to more conventional doses of 12-15 mg milligram However this leads to a very long duration of sensory and motor block far in excess of that required for surgical completion This delays patient discharge from the post-anesthetic recovery unit mobilization and recovery This is at odds with the goals of modern total hip and knee arthroplasty which emphasizes same-day mobilization physiotherapy and even same-day hospital discharge Using lower doses of isobaric bupivacaine on the other hand increases the risk of inadequate or failed spinal anesthesia requiring conversion to general anesthesia
One strategy to address this dilemma which has been employed with great success to date at the Toronto Western Hospital TWH is to use a solution of bupivacaine that is hypobaric relative to CSF This promotes cranial distribution of bupivacaine within the CSF and blockade of the higher spinal nerve roots thus ensuring adequate extent of sensory block even when administering doses as low as 10 mg of bupivacaine This hypobaric bupivacaine solution is prepared by mixing 2 mLmilliliter of isobaric 05 bupivacaine with 1 mL of sterile water The investigators have demonstrated the efficacy of this for successful surgical anesthesia of adequate but not excessive duration in a recently concluded observational study Notably two subjects in the cohort of 60 patients received spinal anesthesia at the L5-S1 level Both patients had adequate sensory block height and duration for commencement and completion of surgery without need for anesthetic supplementation The investigators have performed spinal anesthesia at the L5-S1 level in many other patients over the last 3 years with the same dose of hypobaric bupivacaine and have not encountered failure to date
The purpose of this observational study is to determine the success rate of spinal anesthesia with low-dose 10 mg hypobaric bupivacaine injected into the L5-S1 space in patients undergoing total hip or knee arthroplasty surgery
One strategy is to administer the spinal anesthesia at the L5-S1 space it is least affected by arthritic and degenerative changes and as it is the largest intervertebral space it has the lowest chance of causing spinal cord trauma
However administration of spinal anesthesia at the lowest lumbar intervertebral levels significantly decreases the odds of success of surgical anesthesia This is due to the fact that the standard solution of 05 bupivacaine is isobaric with respect to the cerebrospinal fluid CSF leading to unpredictable distribution within the CSF and inconsistent extent of sensory block It has been shown that an inordinately large dose of 25 mg 5 milliliter of 05 bupivacaine is required to achieve the adequate extent of sensory loss as opposed to more conventional doses of 12-15 mg milligram However this leads to a very long duration of sensory and motor block far in excess of that required for surgical completion This delays patient discharge from the post-anesthetic recovery unit mobilization and recovery This is at odds with the goals of modern total hip and knee arthroplasty which emphasizes same-day mobilization physiotherapy and even same-day hospital discharge Using lower doses of isobaric bupivacaine on the other hand increases the risk of inadequate or failed spinal anesthesia requiring conversion to general anesthesia
One strategy to address this dilemma which has been employed with great success to date at the Toronto Western Hospital TWH is to use a solution of bupivacaine that is hypobaric relative to CSF This promotes cranial distribution of bupivacaine within the CSF and blockade of the higher spinal nerve roots thus ensuring adequate extent of sensory block even when administering doses as low as 10 mg of bupivacaine This hypobaric bupivacaine solution is prepared by mixing 2 mLmilliliter of isobaric 05 bupivacaine with 1 mL of sterile water The investigators have demonstrated the efficacy of this for successful surgical anesthesia of adequate but not excessive duration in a recently concluded observational study Notably two subjects in the cohort of 60 patients received spinal anesthesia at the L5-S1 level Both patients had adequate sensory block height and duration for commencement and completion of surgery without need for anesthetic supplementation The investigators have performed spinal anesthesia at the L5-S1 level in many other patients over the last 3 years with the same dose of hypobaric bupivacaine and have not encountered failure to date
The purpose of this observational study is to determine the success rate of spinal anesthesia with low-dose 10 mg hypobaric bupivacaine injected into the L5-S1 space in patients undergoing total hip or knee arthroplasty surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None