NCT03650504

Brief Summary

Adductor canal (AC) nerve block is a commonly used modality for postoperative pain control after total knee arthroplasty (TKA). When the adductor canal is viewed by ultrasound, the femoral artery and femoral vein can easily be identified, however, the nerve that is to be blocked is often not visible. For this reason, the femoral artery is used as a landmark for the block. There currently are no studies examining the optimal placement of the nerve block catheter relative to the femoral artery in the canal. The goal of this study will be to examine the relationship between nerve catheter tip location relative to femoral artery within the adductor canal for continuous AC nerve blocks. The investigators specifically will compare postoperative pain as well as incidence of vascular puncture during the procedure and time to complete the procedure for two different catheter locations.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 22, 2018

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • AVERAGE PAIN

    Average pain on post operative day 1 following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).

    08:00AM to 24:00 on the first day following surgery

Secondary Outcomes (7)

  • Procedure duration

    Prior to surgery

  • Opioid consumption

    Postoperative days zero and one

  • Distance Ambulated

    Physical Therapy sessions on postoperative day one

  • Worst pain score (NRS 0-10 reported by patient)

    Postoperative day , entire day

  • Number of vascular pictures during placement

    During the catheter placement procedure

  • +2 more secondary outcomes

Study Arms (2)

Above Artery Group

EXPERIMENTAL
Procedure: Above Artery Catheter Placement

Between Artery and Vein Group

ACTIVE COMPARATOR
Procedure: Between Artery and Vein Placement

Interventions

Nerve catheter placed between superficial femoral artery and sartorial muscle

Above Artery Group

Nerve catheter placed between superficial femoral artery and femoral vein

Between Artery and Vein Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing unilateral total knee arthroplasty at UC San Diego with planned placement of an adductor canal catheter at request of surgeon

You may not qualify if:

  • history of allergic reaction to lidocaine or ropivacaine
  • history of peripheral neuropathy, neuropathic pain, or chronic pain requiring opioid medications.
  • Pregnant females and prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

John J Finneran, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 28, 2018

Study Start

August 24, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share