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

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05161221
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.8
• Patients Per Site Per Month: 12

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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 Names: 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 Names: Exparel

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction [8 weeks]

   Participant will record Patient Satisfaction through Visual Analog Scale for pain

2. Post operative pain management [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 [8 weeks]

   Participant will record quadriceps function tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT05161221
• Other Study ID Numbers: sham21D.369
• First Posted: Dec 17, 2021
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen; Naproxen; Oxycodone; Bupivacaine

Study Results

No Results Posted as of Dec 17, 2021