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

NCT05161221 | Unknown Phase 3 FDA Drug

• 1 other identifier: sham21D.369
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; ACL

Outcome Measures

Primary Outcomes (3)

• Patient satisfaction

  Participant will record Patient Satisfaction through Visual Analog Scale for pain

  8 weeks

• 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

• Post operative pain management

  Participant will record quadriceps function tests

  8 weeks

Study Arms (2)

Pre-operative femoral nerve catheter

ACTIVE COMPARATOR

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Tylenol Pill; Procedure: Femoral Nerve Catheter

Pre-operative adductor canal block with liposomal bupivacaine

ACTIVE COMPARATOR

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Tylenol Pill; Drug: Liposomal bupivacaine

Interventions

OxyCODONE 5 mg Oral Tablet DRUG

Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control

Pre-operative adductor canal block with liposomal bupivacaine; Pre-operative femoral nerve catheter

Naproxen 500 Mg DRUG

Participant will receive Naproxen 500 Mg post surgery for pain control

Pre-operative adductor canal block with liposomal bupivacaine; Pre-operative femoral nerve catheter

Tylenol Pill DRUG

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

Pre-operative adductor canal block with liposomal bupivacaine; Pre-operative femoral nerve catheter

Liposomal bupivacaine DRUG

Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)

Also known as: Exparel

Pre-operative adductor canal block with liposomal bupivacaine

Femoral Nerve Catheter PROCEDURE

Participants will receive pre-operative femoral nerve catheter

Also known as: Femoral Nerve Block

Pre-operative femoral nerve catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary anterior cruciate ligament reconstruction with autograft
• Has not used narcotic pain medication in 3 months
• Ages of 18+
• Proficient in the English language
• Willing and able to follow study protocol

You may not qualify if:

• ACL repair, revision surgery, or allograft
• Multi-ligamentous knee injuries
• Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
• Patients taking baseline opioid for other injury
• Dementia or other psychiatric illness that would preclude accurate evaluation
• Pregnant or lactating patients
• Non-English speakers as questionnaires are only available in English

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone; Tablets; Naproxen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Naphthaleneacetic Acids; Naphthalenes; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: December 6, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (1)