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

Primary Purpose

Pain, Postoperative, Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adductor Canal perineural catheter placement
Femoral Nerve perineural catheter placement
Nimbus pump (Infutronix)
Sponsored by
Stanford University
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 SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Adductor Canal Nerve Block group

Femoral Nerve Block group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Score
Participants will report pain on a numeric rating scale

Secondary Outcome Measures

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.
Opioid Use
Total morphine equivalents used through POD 2
CPM compliance
number of hours of reported CPM usage through POD 2

Full Information

First Posted
June 27, 2017
Last Updated
July 21, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03208478
Brief Title
Pain Control for Anterior Cruciate Ligament Reconstruction Patients With Adductor Canal or Femoral Perineural Infusions
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anterior Cruciate Ligament Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Nerve Block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Femoral Nerve Block group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal perineural catheter placement
Other Intervention Name(s)
Adductor Canal block
Intervention Description
Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve perineural catheter placement
Other Intervention Name(s)
Femoral Nerve Block
Intervention Description
Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.
Intervention Type
Device
Intervention Name(s)
Nimbus pump (Infutronix)
Intervention Description
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 Measure Information:
Title
Pain Score
Description
Participants will report pain on a numeric rating scale
Time Frame
Post-operative day 2
Secondary Outcome Measure Information:
Title
Quality of Recovery
Description
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
Title
Opioid Use
Description
Total morphine equivalents used through POD 2
Time Frame
POD 2
Title
CPM compliance
Description
number of hours of reported CPM usage through POD 2
Time Frame
POD 2
Other Pre-specified Outcome Measures:
Title
Quality of Recovery
Description
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
Title
Bolus dose usage
Description
Total volume of patient-administered bolus doses over the course of the infusion
Time Frame
POD 2
Title
Return to Play
Description
Binary variable, whether patient has returned to normal sports activities
Time Frame
3 months
Title
Quadriceps Circumference, percent of baseline
Description
Quadriceps Circumference in cm measured 3 months after surgery, divided by pre-surgery circumference
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis-Horn, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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