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

NCT03208478 | Completed

• 1 other identifier: 41970
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Participants will report pain on a numeric rating scale

  Post-operative day 2

Secondary Outcomes (3)

• Quality of Recovery

  POD 2

• Opioid Use

  POD 2

• CPM compliance

  POD 2

Other Outcomes (4)

• Quality of Recovery

  POD 1

• Bolus dose usage

  POD 2

• Return to Play

  3 months

Study Arms (2)

Adductor Canal Nerve Block group

ACTIVE COMPARATOR

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)

Femoral Nerve Block group

ACTIVE COMPARATOR

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

Adductor Canal perineural catheter placement PROCEDURE

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

Also known as: Adductor Canal block

Adductor Canal Nerve Block group

Femoral Nerve perineural catheter placement PROCEDURE

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

Also known as: Femoral Nerve Block

Femoral Nerve Block group

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.

Adductor Canal Nerve Block group; Femoral Nerve Block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jean Louis-Horn, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Med Ctr Line

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 5, 2017
• Study Start: June 18, 2018
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)