Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04916392
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2021-06-02
Brief Title:
Observation Study of the Pharmacokinetics of Adductor Canal Block
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
An Observational Study of the Pharmacokinetics of Adductor Canal Block Using Liposomal Bupivacaine and Standard Bupivacaine in Total Knee Arthroplasty Patients
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With the aging of the population osteoarthritis of knees and hips become major orthopedic problems worldwide Osteoarthritis of the knees and hips is associated with a significant pain problem and functional disability Total joints replacement is the ultimate surgical procedure to deal with such problems Multimodal analgesia including periarticular local infiltration of analgesia LIA regional nerve block using adductor canal block ACB opioid and non-opioid have been shown to be effective in managing postoperative pain Regional nerve block using femoral nerve block or adductor canal block ACB is also a well-established analgesic technique after total knee replacement Standard bupivacaine SB levobupivacaine ropivacaine were used in ACB in these studies Whether combining ACB with periarticular LIA has the additional benefit of prolonging analgesia or with synergistic effect remains controversial because the number of RCTs conducted is not enough Liposomal bupivacaine LB may further prolong the analgesic effect of ACB as the therapeutic levels of bupivacaine are below the toxic range and sustained for 72 hours after injection The purpose of this study is to evaluate the safety and systemic levels of serum bupivacaine following adductor canal block using LB 665mg in patients undergoing TKA with LIA over a 72-hour period This also serves as a pilot study to determine the dose and timing of blood taking for serum bupivacaine level of a previously IRB approved study - Comparing the efficacy of combining periarticular local infiltration of analgesia and adductor canal block using liposomal bupivacaine and standard bupivacaine- A prospective randomized controlled trial
Detailed Description:
After signing the consent form participants will receive LIA with ACB using 5ml of 133 liposomal bupivacaine with 5ml of 09 normal saline
Participants will receive routine preoperative intraoperative and postoperative treatments like other patients undergoing total knee replacement
Blood will be collected during induction at 1 hour 2 hours 4 hours 8 hours and 12 hours after the performance of ACB through a designated 14-gauge cannula and also at 24 48 and 72 hours after the operation during routine blood taking
Participants will receive routine preoperative intraoperative and postoperative treatments like other patients undergoing total knee replacement
Blood will be collected during induction at 1 hour 2 hours 4 hours 8 hours and 12 hours after the performance of ACB through a designated 14-gauge cannula and also at 24 48 and 72 hours after the operation during routine blood taking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None