Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
154 participants
INTERVENTIONAL
2023-09-30
2024-09-30
Brief Summary
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The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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isolated adductor canal block (ACB)
Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
Bupivacaine HCl 0.5% Injectable Solution
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
Dexamethasone
During adductor canal block participants will receive 2mg Dexamethasone
Percocet 5Mg-325Mg Tablet
Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
isolated adductor canal block (ACB) + IPACK
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
Bupivacaine HCl 0.5% Injectable Solution
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
Dexamethasone
During adductor canal block participants will receive 2mg Dexamethasone
Infiltration between Popliteal Artery and Capsule of the knee (iPACK)
Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone
Percocet 5Mg-325Mg Tablet
Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
Interventions
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Bupivacaine HCl 0.5% Injectable Solution
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
Dexamethasone
During adductor canal block participants will receive 2mg Dexamethasone
Infiltration between Popliteal Artery and Capsule of the knee (iPACK)
Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone
Percocet 5Mg-325Mg Tablet
Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ftjo21D.1099
Identifier Type: -
Identifier Source: org_study_id
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