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

Pain, Postoperative Clinical Trial

Official title:

Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05161221
• Other study ID #: sham21D.369
• Status: Enrolling by invitation
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• ACL
• Pain, Postoperative

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