Pain, Postoperative, ACL
Conditions
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.
Interventions
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
DRUGNaproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control
DRUGTylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
DRUGLiposomal bupivacaine
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
PROCEDUREFemoral Nerve Catheter
Participants will receive pre-operative femoral nerve catheter
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 8 weeks | Participant will record Patient Satisfaction through Visual Analog Scale for pain |
| Post operative pain management | 8 weeks | Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments. |
Countries
United States
Outcome results
None listed