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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208478
• Other study ID #: 41970
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

covery score, opioid use, and CPM compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Pain, Postoperative

Intervention

Procedure:
• Adductor Canal perineural catheter placement
Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.
• Femoral Nerve perineural catheter placement
Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Bolus dose usage	Total volume of patient-administered bolus doses over the course of the infusion	POD 2
Other	Return to Play	Binary variable, whether patient has returned to normal sports activities	3 months
Other	Quadriceps Circumference, percent of baseline	Quadriceps Circumference in cm measured 3 months after surgery, divided by pre-surgery circumference	3 months
Primary	Pain Score	Participants will report pain on a numeric rating scale	Post-operative day 2
Secondary	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
Secondary	Opioid Use	Total morphine equivalents used through POD 2	POD 2
Secondary	CPM compliance	number of hours of reported CPM usage through POD 2	POD 2