Brief Title
Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
Official Title
Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
Brief Summary
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Patient satisfaction
Condition
Pain, Postoperative
Intervention
OxyCODONE 5 mg Oral Tablet
Study Arms / Comparison Groups
Pre-operative femoral nerve catheter
Description: participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
154
Start Date
December 6, 2021
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria:
1. Patients undergoing primary anterior cruciate ligament reconstruction with autograft
2. Has not used narcotic pain medication in 3 months
3. Ages of 18+
4. Proficient in the English language
5. Willing and able to follow study protocol
Exclusion Criteria:
1. ACL repair, revision surgery, or allograft
2. Multi-ligamentous knee injuries
3. Cartilage procedures that prevented adherence to the immediate weightbearing and range
of motion rehabilitation protocol
4. Patients taking baseline opioid for other injury
5. Dementia or other psychiatric illness that would preclude accurate evaluation
6. Pregnant or lactating patients
7. Non-English speakers as questionnaires are only available in English
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05161221
Organization ID
sham21D.369
Responsible Party
Sponsor
Study Sponsor
Rothman Institute Orthopaedics
Study Sponsor
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Verification Date
December 2021