Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04003506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2019-06-26
Brief Title:
Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Comparing the Efficacy of Combining Periarticular Local Infiltration of Analgesia and Adductor Canal Block Using Liposomal Bupivacaine and Standard Bupivacaine in Total Knee Arthroplasty - A Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
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 aging of population osteoarthritis of knees and hips become major orthopaedic problems in Hong Kong Osteoarthritis of knees and hips are associated with significant pain problem and functional disability Total joints replacement is the ultimate surgical procedures to deal with such problems
However total joints replacement is associated with significant tissue damage and post-operative pain problems which would affect post-operative recovery and rehabilitation
The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints However there are around 20-30 of patients would develop significant pain problem despite uncomplicated total knee replacement It accounts for major post-operative problems and burdens
Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management which reduces the post-operative pain score However despite using of multi-modal analgesic technique pain after total joint replacement is still the most unsolved issue It prolongs the recovery period and increases post-operative analgesic consumptions
Multimodal analgesia including periarticular local infiltration of analgesia LIA regional nerve block opioid and non-opioid have been shown to be effective in managing postoperative pain
Periarticular LIA has been shown to be an effective way of pain management Regional nerve block using femoral nerve block or adductor canal block ACB is also a well-established anlagesic technique after total knee replacement Comparing with femoral nerve block it involves more sensory blockade so has the advantage of quadriceps sparing less affecting the post-operative mobilization
From most recent systematic reviews and randomized controlled trials it becomes clear that periarticular LIA has better pain control with less opioid consumption than ACB alone However duration of a single-dose LIA may not be long enough after total knee replacement Recent meta-analysis has shown that combined ACB with LIA could significantly reduce pain scores and morphine consumption compared LIA alone after TKA Standard bupivacaine levobupivocaine ropivocaine were used in ACB in these studies They are local anaesthetic with half-life ranging from 3-6 hours
With the availability of liposomal bupivacaine LB ACB using LB may further prolong the analgesic effect of ACB as the therapeutic levels of bupivacaine which are below the toxic range and sustained for 72 hours after injection Therefore the issue is whether ACB using LB has even longer analgesic effect than plain bupivacaine or ropivacaine There was only one study directly compared ACB using LB and 01 ropivociane infusion It was shown that LB had significant impact in pain control in the first 36 hours However this was a retrospective study and there was difference in delivery of local anaesthetics single shot injection for liposomal bupivacaine but continuous infusion for ropivacaine
The primary aim of this study is to investigate whether ACB using liposomal bupivacaine has even longer analgesic effect than standard bupivacaine SB and its cost effectiveness Secondary aims are to evaluate the pharmacokinetic data of standard bupivacaine and liposomal bupivacaine in adductor canal block and pharmacokinetic data of ropivocaine level in LIA
However total joints replacement is associated with significant tissue damage and post-operative pain problems which would affect post-operative recovery and rehabilitation
The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints However there are around 20-30 of patients would develop significant pain problem despite uncomplicated total knee replacement It accounts for major post-operative problems and burdens
Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management which reduces the post-operative pain score However despite using of multi-modal analgesic technique pain after total joint replacement is still the most unsolved issue It prolongs the recovery period and increases post-operative analgesic consumptions
Multimodal analgesia including periarticular local infiltration of analgesia LIA regional nerve block opioid and non-opioid have been shown to be effective in managing postoperative pain
Periarticular LIA has been shown to be an effective way of pain management Regional nerve block using femoral nerve block or adductor canal block ACB is also a well-established anlagesic technique after total knee replacement Comparing with femoral nerve block it involves more sensory blockade so has the advantage of quadriceps sparing less affecting the post-operative mobilization
From most recent systematic reviews and randomized controlled trials it becomes clear that periarticular LIA has better pain control with less opioid consumption than ACB alone However duration of a single-dose LIA may not be long enough after total knee replacement Recent meta-analysis has shown that combined ACB with LIA could significantly reduce pain scores and morphine consumption compared LIA alone after TKA Standard bupivacaine levobupivocaine ropivocaine were used in ACB in these studies They are local anaesthetic with half-life ranging from 3-6 hours
With the availability of liposomal bupivacaine LB ACB using LB may further prolong the analgesic effect of ACB as the therapeutic levels of bupivacaine which are below the toxic range and sustained for 72 hours after injection Therefore the issue is whether ACB using LB has even longer analgesic effect than plain bupivacaine or ropivacaine There was only one study directly compared ACB using LB and 01 ropivociane infusion It was shown that LB had significant impact in pain control in the first 36 hours However this was a retrospective study and there was difference in delivery of local anaesthetics single shot injection for liposomal bupivacaine but continuous infusion for ropivacaine
The primary aim of this study is to investigate whether ACB using liposomal bupivacaine has even longer analgesic effect than standard bupivacaine SB and its cost effectiveness Secondary aims are to evaluate the pharmacokinetic data of standard bupivacaine and liposomal bupivacaine in adductor canal block and pharmacokinetic data of ropivocaine level in LIA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None