Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.
No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.
The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing primary anterior cruciate ligament reconstruction with autograft
- Has not used narcotic pain medication in 3 months
- Ages of 18+
- Proficient in the English language
- Willing and able to follow study protocol
Exclusion Criteria:
- ACL repair, revision surgery, or allograft
- Multi-ligamentous knee injuries
- Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
- Patients taking baseline opioid for other injury
- Dementia or other psychiatric illness that would preclude accurate evaluation
- Pregnant or lactating patients
- Non-English speakers as questionnaires are only available in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Pre-operative femoral nerve catheter
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
|
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Participant will receive Naproxen 500 Mg post surgery for pain control
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Participants will receive pre-operative femoral nerve catheter
Other Names:
|
|
ACTIVE_COMPARATOR: Pre-operative adductor canal block with liposomal bupivacaine
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
|
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Participant will receive Naproxen 500 Mg post surgery for pain control
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: 8 weeks
|
Participant will record Patient Satisfaction through Visual Analog Scale for pain
|
8 weeks
|
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Post operative pain management
Time Frame: 8 weeks
|
Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments.
|
8 weeks
|
|
Post operative pain management
Time Frame: 8 weeks
|
Participant will record quadriceps function tests
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Anesthetics, Local
- Gout Suppressants
- Acetaminophen
- Bupivacaine
- Oxycodone
- Naproxen
Other Study ID Numbers
- sham21D.369
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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