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Local Anesthetic
Nerve Block for Postoperative Pain After ACL Surgery
Phase 3
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.
Be older than 18 years old
Must not have
Revision ACLR
Age less than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group
Approved for 60 Other Conditions
Summary
This trial is investigating the role of a new type of nerve block in reducing pain and opioid usage for patients undergoing ACL surgery.
Who is the study for?
This trial is for patients undergoing their first ACL reconstruction due to a tear, including those with additional meniscus surgery. It's not for people under 18, those having revision surgery, on worker's compensation, or pregnant women.
What is being tested?
The study tests pain management techniques after ACL surgery. It compares the effectiveness of an adductor canal block (ACB) alone versus ACB combined with iPACK in reducing pain and opioid use post-surgery.
What are the potential side effects?
Possible side effects may include discomfort at injection sites, potential nerve damage from blocks leading to weakness or numbness, allergic reactions to medications used like Bupivacaine or Dexamethasone, and typical Percocet side effects such as nausea and constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having ACL reconstruction, with or without meniscus surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am getting or have had a second ACL surgery.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post operative pain management
Post operative pain management 2
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
2Treatment groups
Active Control
Group I: isolated adductor canal block (ACB)Active Control3 Interventions
Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
Group II: isolated adductor canal block (ACB) + IPACKActive Control4 Interventions
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
Find a Location
Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
126 Previous Clinical Trials
22,430 Total Patients Enrolled
8 Trials studying Infections
1,433 Patients Enrolled for Infections