Adductor Canal BlockNCT03008564
Adductor Canal Block Ultrasound Anatomy in Volunteers
An observational study of Adductor Canal Block and Postop Analgesia for Knee, run by University of Iowa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adductor Canal Block, Postop Analgesia for Knee
- What is being tested?
- Ultrasound scanning of the lower limb in volunteers
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 16 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age 18-75 years, body mass index 18-35 kg/m2
Who cannot join
- no previous surgery or complaints from the lower extremity region
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246
About this study
Official title: 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:
- Point A: midway point between the ASIS and base of patella
- 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)
Read more
We want to determine ultrasound anatomy in healthy volunteers by:
- Measuring the distance between Point A and Point B
- 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
Read the 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:
- 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:
- Base of patella to Point A
- Base of patella to Point B
- Apex of the femoral triangle
- Conditions
- Adductor Canal Block, Postop Analgesia for Knee
- Being tested
- Ultrasound scanning of the lower limb in volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanning of the lower limb in volunteersOther
Several reference points will be marked by anatomical landmarks and/or ultrasound: the anterior superior iliac spine; base of patella; apex of the femoral triangle A measuring tape will be used to measure the anterior superior iliac spine (landmark); the base of the patella (landmark); apex of femoral triangle (ultrasound); and distal most portion of adductor canal (Point B described earlier; ultrasound). We will then measure the ASIS to: 1) base of patella; 2) apex of femoral triangle; and 3) Point B. We will repeat the same procedure on the opposite leg. Once complete, the volunteer will be allowed to dress and leave. The procedure should take approximately 10-20 minutes for each volunteer. The following things will be recorded for each subject:
- Age
- Gender
- Weight
- Height
- BMI
- Distance of ASIS to base of patella
- Distance of Point A to base of patella
- Distance of Point B to base of patella
- Distance of apex of femoral triangle to base of patella
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement 1
The distance in cm between Point A and Point B
Measured: One time assessment done during Ultrasound scanning of the lower extremity
Secondary outcomes (3)
Measurement 2
The distance in cm between Point A and base of patella
Measured: One time assessment done during Ultrasound scanning of the lower extremity
Measurement 3
The distance in cm between Point B and base of patella
Measured: One time assessment done during Ultrasound scanning of the lower extremity
Measurement 4
The distance in cm between Apex of femoral triangle and base of patella
Measured: One time assessment done during Ultrasound scanning of the lower extremity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adductor Canal BlockStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yatish Siddapura Ranganath, University of Iowa
- Investigators
- Amanda Yap, MBBS, Principal investigator, 319-356-1616
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008564
- Sponsor's protocol ID
- 201612345
- Status last verified
- Nov 2017
- First submitted
- 28 Dec 2016
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.
PubMed 24747312Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.
PubMed 17618402Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
PubMed 24121608Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
PubMed 25140514Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.
PubMed 26079358Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PubMed 19916251
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining The Location and Ultrasound Anatomy of Two Previously Described Adductor Canal Block Approaches in Volunteers.
- ClinicalTrials.gov ID
- NCT03008564
- Acronym / sponsor ID
- 201612345
- Conditions
- Adductor Canal Block, Postop Analgesia for Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Point A: midway point between the ASIS and base of patella
- 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:
- Measuring the distance between Point A and Point B
- 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
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:
- 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:
- Base of patella to Point A
- Base of patella to Point B
- Apex of the femoral triangle
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- age 18-75 years, body mass index 18-35 kg/m2
Key exclusion criteria (1 listed)
- no previous surgery or complaints from the lower extremity region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanning of the lower limb in volunteersSeveral reference points will be marked by anatomical landmarks and/or ultrasound: the anterior superior iliac spine; base of patella; apex of the femoral triangle A measuring tape will be used to measure the anterior superior iliac spine (landmark); the base of the patella (landmark); apex of femoral triangle (ultrasound); and distal most portion of adductor canal (Point B described earlier; ultrasound). We will then measure the ASIS to: 1) base of patella; 2) apex of femoral triangle; and 3) Point B. We will repeat the same procedure on the opposite leg. Once complete, the volunteer will be allowed to dress and leave. The procedure should take approximately 10-20 minutes for each volunteer. The following things will be recorded for each subject: * Age * Gender * Weight * Height * BMI * Distance of ASIS to base of patella * Distance of Point A to base of patella * Distance of Point B to base of patella * Distance of apex of femoral triangle to base of patella | Other | – |
Primary outcome
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
3 secondary outcomes
Measurement 2
Time frame: 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
Measurement 4
Time frame: One time assessment done during Ultrasound scanning of the lower extremity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Background: PubMed 24747312Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.
- Background: PubMed 17618402Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.
- Background: PubMed 24121608Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
- Background: PubMed 25140514Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
- Background: PubMed 26079358Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.
- Background: PubMed 19916251Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Yap, MBBS principal investigator
319-356-1616
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adductor Canal Block and Postop Analgesia for Knee, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement 1 (time frame: One time assessment done during Ultrasound scanning of the lower extremity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008564, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.