Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
Primary Purpose
Pain, Postoperative, ACL
Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OxyCODONE 5 mg Oral Tablet
Naproxen 500 Mg
Tylenol Pill
Liposomal bupivacaine
Femoral Nerve Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pre-operative femoral nerve catheter
Pre-operative adductor canal block with liposomal bupivacaine
Arm Description
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Outcomes
Primary Outcome Measures
Patient satisfaction
Participant will record Patient Satisfaction through Visual Analog Scale for pain
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.
Post operative pain management
Participant will record quadriceps function tests
Secondary Outcome Measures
Full Information
NCT ID
NCT05161221
First Posted
December 3, 2021
Last Updated
December 3, 2021
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT05161221
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 6, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, ACL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-operative femoral nerve catheter
Arm Type
Active Comparator
Arm Description
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Arm Title
Pre-operative adductor canal block with liposomal bupivacaine
Arm Type
Active Comparator
Arm Description
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Intervention Type
Drug
Intervention Name(s)
OxyCODONE 5 mg Oral Tablet
Intervention Description
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Intervention Type
Drug
Intervention Name(s)
Naproxen 500 Mg
Intervention Description
Participant will receive Naproxen 500 Mg post surgery for pain control
Intervention Type
Drug
Intervention Name(s)
Tylenol Pill
Intervention Description
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Catheter
Other Intervention Name(s)
Femoral Nerve Block
Intervention Description
Participants will receive pre-operative femoral nerve catheter
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Participant will record Patient Satisfaction through Visual Analog Scale for pain
Time Frame
8 weeks
Title
Post operative pain management
Description
Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments.
Time Frame
8 weeks
Title
Post operative pain management
Description
Participant will record quadriceps function tests
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
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