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

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ClinicalTrials.gov Identifier: NCT05161221
Recruitment Status : Enrolling by invitation
First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative ACL Drug: OxyCODONE 5 mg Oral Tablet Drug: Naproxen 500 Mg Drug: Tylenol Pill Drug: Liposomal bupivacaine Procedure: Femoral Nerve Catheter Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
Estimated Study Start Date : December 6, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pre-operative femoral nerve catheter
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
 Drug: OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control

Drug: Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control

Drug: Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control

Procedure: Femoral Nerve Catheter
Participants will receive pre-operative femoral nerve catheter
Other Name: Femoral Nerve Block
Active Comparator: Pre-operative adductor canal block with liposomal bupivacaine
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
 Drug: OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control

Drug: Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control

Drug: Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control

Drug: Liposomal bupivacaine
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Other Name: Exparel


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 8 weeks ]
    Participant will record Patient Satisfaction through Visual Analog Scale for pain

  2. Post operative pain management [ Time Frame: 8 weeks ]
    Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments.

  3. Post operative pain management [ Time Frame: 8 weeks ]
    Participant will record quadriceps function tests


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161221


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT05161221    
Other Study ID Numbers: sham21D.369
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Naproxen
Oxycodone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics