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OpenTrials
Completed

NCT Number: NCT03208478

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

covery score, opioid use, and CPM compliance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor Canal perineural catheter placement

Procedure

Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.

Other names: Adductor Canal block

Femoral Nerve perineural catheter placement

Procedure

Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.

Other names: Femoral Nerve Block

Nimbus pump (Infutronix)

Device

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 outcomes

  1. Pain Score

    Time frame: Post-operative day 2

    Participants will report pain on a numeric rating scale

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Adductor Canal or Femoral Perineural Infusions

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2017
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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