NCT02786888

Brief Summary

Early ambulation after knee replacement surgery is made possible in large part by providing safe and effective pain control. Peripheral nerve blocks are increasingly used for postoperative analgesia since they can provide excellent pain relief and minimize the need for opioid analgesics. Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists at the University of Utah. This block is unique in that it spares motor function in the lower extremity. Since 2009, a number of publications have described the successful use of ACB for pain management after total knee arthroplasty (TKA), anterior cruciate ligament (ACL) reconstruction, and other procedures of the knee. As a component of multi-modal analgesia, ACB can provide effective postoperative pain control and facilitate early hospital discharge. Although it is widely utilized, the ACB block can be technically difficult to perform since it requires injection in immediate proximity to the femoral artery and vein. In patients with a large thigh circumference, ultrasound can be challenging since the femoral vessels are deeper and more difficult to visualize. This presents the possibility of vessel trauma and/or intravascular injection of local anesthetic. The investigators have implemented a new technique for performing the ACB. This block is performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm. Injection through the fenestrated needle produces effective distribution of local anesthetic to nerves of the adductor canal without immediate proximity to the femoral artery and vein. The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible even in patients with very large thigh circumference. In summary, early experience with the US guided ACB block performed with a fenestrated block needle suggests that it is technically easier and potentially safer to perform than blocks performed with a conventional needle. This study should be performed prospectively in order to ensure accurate data comparing the two needles. A retrospective review of blocks performed using a conventional needle would not provide accurate data with respect to the number of attempts, time required to perform the blocks or the resulting sensory changes after performing the nerve block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

May 17, 2016

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The efficiency in performing nerve block

    The number of attempts during block placement as well as the number of times the needle must be repositioned during block placement. This will simply be recorded as a whole number by the study nurse. The number of unintended vascular punctures observed by a study nurse will be recorded.

    this metric will be obtained while the nerve block is being performed

Secondary Outcomes (1)

  • pain control as a measure of nerve block effectiveness will be recorded using a verbal analog scale between 1 and 10. Opioid requirements will be recorded as a total number of milligrams received.

    this metric will be recorded during the first 24 hours after surgery

Study Arms (2)

conventional needle

conventional needle used

fenestrated needle

fenestrated needle used

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients for elective knee arthroplasty

You may qualify if:

  • all TKA patients

You may not qualify if:

  • refuse nerve block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Swenson JD, Pollard JE, Peters CL, Anderson MB, Pace NL. Randomized controlled trial of a simplified adductor canal block performed for analgesia following total knee arthroplasty. Reg Anesth Pain Med. 2019 Mar;44(3):348-353. doi: 10.1136/rapm-2018-100070. Epub 2019 Jan 23.

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jeff Swenson, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 17, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations