Clinical trial NCT05161221: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
ACL
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 8 weeks
measure: Post operative pain management
timeFrame: 8 weeks
measure: Post operative pain management
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: