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CompletedNCT03208478Updated Jul 24, 2023

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

An interventional study of Adductor Canal perineural catheter placement and Femoral Nerve perineural catheter placement in Pain, Postoperative and Anterior Cruciate Ligament Injury, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

covery score, opioid use, and CPM compliance.

02

Conditions studied

  • Pain, Postoperative
  • Anterior Cruciate Ligament Injury
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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 · Device: Nimbus pump (Infutronix)

  • 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 · Device: Nimbus pump (Infutronix)

Interventions

  • ProcedureAdductor Canal perineural catheter placement

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

    Also known as: Adductor Canal block

  • ProcedureFemoral Nerve perineural catheter placement

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

    Also known as: Femoral Nerve Block

  • DeviceNimbus 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.

06

What researchers measure

Primary outcomes

  1. Pain Score

    Participants will report pain on a numeric rating scale

    Time frame: Post-operative day 2

Secondary outcomes

  1. Quality of Recovery

    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.

    Time frame: POD 2

  2. Opioid Use

    Total morphine equivalents used through POD 2

    Time frame: POD 2

  3. CPM compliance

    number of hours of reported CPM usage through POD 2

    Time frame: POD 2

Other outcomes

  1. Quality of Recovery

    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.

    Time frame: POD 1

  2. Bolus dose usage

    Total volume of patient-administered bolus doses over the course of the infusion

    Time frame: POD 2

  3. Return to Play

    Binary variable, whether patient has returned to normal sports activities

    Time frame: 3 months

  4. Quadriceps Circumference, percent of baseline

    Quadriceps Circumference in cm measured 3 months after surgery, divided by pre-surgery circumference

    Time frame: 3 months

07

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03208478
Lead sponsor
Stanford University
Responsible party
Jean-Louis Horn (Professor-Med Ctr Line, Stanford University) — Principal investigator
First posted
Jul 5, 2017
Start date
Jun 18, 2018
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Jul 24, 2023

Study contacts

Jean Louis-Horn, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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