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

A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anterior Cruciate Ligament Injury
• Intervention / Treatment: Procedure: Adductor Canal perineural catheter placement; Device: Nimbus pump (Infutronix); Procedure: Femoral Nerve perineural catheter placement

Detailed Description

covery score, opioid use, and CPM compliance.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.	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.; Procedure: Femoral Nerve perineural catheter placement; Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.; Other Names: Femoral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Participants will report pain on a numeric rating scale	Post-operative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	POD 2
Opioid Use	Total morphine equivalents used through POD 2	POD 2
CPM compliance	number of hours of reported CPM usage through POD 2	POD 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	POD 1
Bolus dose usage	Total volume of patient-administered bolus doses over the course of the infusion	POD 2
Return to Play	Binary variable, whether patient has returned to normal sports activities	3 months
Quadriceps Circumference, percent of baseline	Quadriceps Circumference in cm measured 3 months after surgery, divided by pre-surgery circumference	3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jean Louis-Horn, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Knee Injuries; Pain, Postoperative; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 41970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No