Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

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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

, , 


Verification Date

December 2021