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

Not Applicable

Completed

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

• Registration Number: NCT03208478
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Study Start: 2018-06-18
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor Canal Nerve Block group	Nimbus pump (Infutronix)	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 Block group	Nimbus pump (Infutronix)	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.
Adductor Canal Nerve Block group	Adductor Canal perineural catheter placement	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 Block group	Femoral Nerve perineural catheter placement	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.

Primary Outcome Measures

Name	Time	Method
Pain Score	Post-operative day 2	Participants will report pain on a numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery	POD 2	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	POD 2	Total morphine equivalents used through POD 2
CPM compliance	POD 2	number of hours of reported CPM usage through POD 2

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States