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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
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
December 3, 2021
Last Updated
December 3, 2021
Sponsor
Rothman Institute Orthopaedics
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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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