Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Control for Anterior Cruciate Ligament Reconstruction Patients With Adductor Canal or Femoral Perineural Infusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208478
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Jean-Louis Horn, Stanford University

Brief Summary:
Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. Recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("Adductor Canal" and "Femoral"). However, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. The investigators plan to study this by randomizing patients presenting for ACL reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and CPM compliance.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Anterior Cruciate Ligament Injury Procedure: Adductor Canal perineural catheter placement Procedure: Femoral Nerve perineural catheter placement Device: Nimbus pump (Infutronix) Not Applicable

Detailed Description:
covery score, opioid use, and CPM compliance.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Adductor Canal or Femoral Perineural Infusions
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adductor Canal Nerve Block group
Adductor Canal perineural catheter placement. Adductor Canal continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed in the adductor canal. A Nimbus pump (Infutronix) will be delivering the medication.
Procedure: Adductor Canal perineural catheter placement
Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.
Other Name: Adductor Canal block

Device: Nimbus pump (Infutronix)
This is a FDA approved infusion device that is used in standard of care to store pain medication and to provide patients with continuous pain control medication at a set rate. This pump will be used for both the Adductor Canal and Femoral Nerve block participants.

Active Comparator: Femoral Nerve Block group
Femoral Nerve perineural catheter placement. Femoral continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed near the femoral nerve. A Nimbus pump (Infutronix) will be delivering the medication.
Procedure: Femoral Nerve perineural catheter placement
Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.
Other Name: Femoral Nerve Block

Device: Nimbus pump (Infutronix)
This is a FDA approved infusion device that is used in standard of care to store pain medication and to provide patients with continuous pain control medication at a set rate. This pump will be used for both the Adductor Canal and Femoral Nerve block participants.




Primary Outcome Measures :
  1. Pain Score [ Time Frame: Post-operative day 2 ]
    Participants will report pain on a numeric rating scale


Secondary Outcome Measures :
  1. Quality of Recovery [ Time Frame: POD 2 ]
    The Quality of Recovery 15 (QoR 15) is a 15-item questionnaire that is often used to assess how patients are doing in their post-operative course. This survey will be used to assess participants' quality of recovery after ACL reconstructive surgery.

  2. Opioid Use [ Time Frame: POD 2 ]
    Total morphine equivalents used through POD 2

  3. CPM compliance [ Time Frame: POD 2 ]
    number of hours of reported CPM usage through POD 2


Other Outcome Measures:
  1. Quality of Recovery [ Time Frame: POD 1 ]
    The Quality of Recovery 15 (QoR 15) is a 15-item questionnaire that is often used to assess how patients are doing in their post-operative course. This survey will be used to assess participants' quality of recovery after ACL reconstructive surgery.

  2. Bolus dose usage [ Time Frame: POD 2 ]
    Total volume of patient-administered bolus doses over the course of the infusion

  3. Return to Play [ Time Frame: 3 months ]
    Binary variable, whether patient has returned to normal sports activities

  4. Quadriceps Circumference, percent of baseline [ Time Frame: 3 months ]
    Quadriceps Circumference in cm measured 3 months after surgery, divided by pre-surgery circumference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >18 years
  • ASA physical status I, II, or III
  • Scheduled for ACL reconstruction surgery with patellar autograft

Exclusion Criteria:

  • Pregnancy
  • Incarceration
  • Age <18
  • BMI >35
  • Pre-operative opioid use >15 mg morphine equivalents per day
  • Inability to communicate with investigators by telephone
  • Pre-existing neuropathy of the operative extremity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208478


Contacts
Layout table for location contacts
Contact: Jean Louis-Horn, MD 503-381-1645 hornj@stanford.edu
Contact: Swaroop Mistry, MS smistry3@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Archana Verma         
Principal Investigator: Jean Louis-Horn, MD         
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Jean Louis-Horn, MD Stanford University
Layout table for additonal information
Responsible Party: Jean-Louis Horn, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier: NCT03208478    
Other Study ID Numbers: 41970
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Anterior Cruciate Ligament Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Knee Injuries
Leg Injuries
Wounds and Injuries