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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05161221
Other study ID # sham21D.369
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date December 6, 2021
Est. completion date December 31, 2022

Study information

Verified date December 2021
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 154
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control
Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Liposomal bupivacaine
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Procedure:
Femoral Nerve Catheter
Participants will receive pre-operative femoral nerve catheter

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction Participant will record Patient Satisfaction through Visual Analog Scale for pain 8 weeks
Primary Post operative pain management Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments. 8 weeks
Primary Post operative pain management Participant will record quadriceps function tests 8 weeks
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