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

NCT ID: NCT03208478

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2023-04-30

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.

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Adductor Canal perineural catheter placement

Intervention Type: PROCEDURE

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

Nimbus pump (Infutronix)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Femoral Nerve perineural catheter placement

Intervention Type: PROCEDURE

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

Nimbus pump (Infutronix)

Intervention Type: 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.

Interventions

Adductor Canal perineural catheter placement

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

Intervention Type: PROCEDURE

Femoral Nerve perineural catheter placement

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

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Adductor Canal block; Femoral Nerve Block

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Louis Horn

Professor-Med Ctr Line

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Louis-Horn, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

41970

Identifier Type: -

Identifier Source: org_study_id