Adductor Canal Block Ultrasound Anatomy in Volunteers

December 5, 2017 updated by: Yatish Siddapura Ranganath, University of Iowa

Determining The Location and Ultrasound Anatomy of Two Previously Described Adductor Canal Block Approaches in Volunteers.

There has been dispute about the location at which the adductor canal block should be performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal blocks with the 'point of entry' being:

  1. Point A: midway point between the ASIS and base of patella
  2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes the popliteal artery as it traverses away from the sartorius muscle towards the femur at the adductor hiatus (2)

We want to determine ultrasound anatomy in healthy volunteers by:

  1. Measuring the distance between Point A and Point B
  2. Studying the ultrasound anatomy at Point A and B - Determine their location with respect to the adductor canal and femoral triangle.

This will allow us to determine which is the best site for performing an adductor canal block

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

It is important to answer the primary question because of the variable length of the adductor canal and we would like to determine the optimal position to perform the adductor canal block.

The adductor canal typically contains the saphenous nerve, nerve to vastus medialis muscle and on occasion, the obturator nerve (1). The roof of adductor canal is the vasto-adductor membrane and its length is reported to range from 5.5 cm to 15 cm with a mean of 7.6 cm2 and would suggest the length of the AC is variable. We would like to determine the length of the AC with the use of ultrasound. The AC would be determined to begin at the apex of the femoral triangle and end just proximal to the adductor hiatus. The length and location of the AC would be important to characterize as the volume of local anesthetic used and associated quadriceps weakness could be of significance in a shorter AC.

There has been dispute about the location at which the adductor canal block should be performed (3-6). Point A has been disputed to be within the femoral triangle and would therefore be a femoral nerve block as suggested by a small body of evidence (4-5). Clinically, it is unclear if there is a difference between quadriceps muscle weakness between the two approaches although it could be hypothesized placing a block at point A would lead to more quadriceps muscle weakness. With information gathered from this study, we plan to perform a clinical study by performing the nerve blocks at these two points with different volumes of local anesthetic and compare the amount analgesia and motor weakness between the two different approaches.

60 Volunteers (30 male and 30 female) aged between 18 to 75 years with a body mass index of 18 to 35 kg/m2 will be included in this study. Volunteers with previous surgery or deformities of the lower extremity will be excluded from the study

This is an observational study without a control group. Several reference points will be marked by anatomical landmarks and/or ultrasound:

A. the anterior superior iliac spine (landmark); B. the base of the patella (landmark); C. apex of femoral triangle (ultrasound); and D. distal most portion of adductor canal (Point B described earlier; ultrasound).

The primary outcome measure we are looking at is the distance between Point A and Point B.

We also plan to measure the distance (in centimeters) from:

  1. Base of patella to Point A
  2. Base of patella to Point B
  3. Apex of the femoral triangle

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We aim to recruit volunteers who principally are healthcare employees at UIHC who mainly work in the Main Operating Rooms and Ambulatory Surgical Center Operating Rooms, mainly due to ease of access to ultrasonographic equipment. The subjects include anesthesiologists, certified registered nurse anesthetists, residents, interns, nurses, volunteers, technicians, administrative staff and other members of staff working in these areas.

Description

Inclusion Criteria:

  • age 18-75 years, body mass index 18-35 kg/m2

Exclusion Criteria:

  • no previous surgery or complaints from the lower extremity region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement 1
Time Frame: One time assessment done during Ultrasound scanning of the lower extremity
The distance in cm between Point A and Point B
One time assessment done during Ultrasound scanning of the lower extremity

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement 2
Time Frame: One time assessment done during Ultrasound scanning of the lower extremity
The distance in cm between Point A and base of patella
One time assessment done during Ultrasound scanning of the lower extremity
Measurement 3
Time Frame: One time assessment done during Ultrasound scanning of the lower extremity
The distance in cm between Point B and base of patella
One time assessment done during Ultrasound scanning of the lower extremity
Measurement 4
Time Frame: One time assessment done during Ultrasound scanning of the lower extremity
The distance in cm between Apex of femoral triangle and base of patella
One time assessment done during Ultrasound scanning of the lower extremity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Iowa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda Yap, MBBS, 319-356-1616

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201612345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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