Knee ArthropathyNCT04298476
Defining the Optimal Location to Place an Adductor Canal Block
A study testing Placement of an adductor canal nerve block in people with Knee Arthropathy, run by Drexel University at 1 site in United States.
Trial summary
The aim of the current project is to address a gap in the existing literature related to optimal placement of local anesthetic for an adductor canal (AC) block. The current study seeks to examine whether placement of the local anesthetic in the AC for knee surgery is more effective at reducing post-operative pain… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Placement of an adductor canal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Dec 2020
- Phase
- Interventional
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient is 7 to ≤ 17 years of age
- Patient at St. Christopher's Hospital for Children
- Receiving a knee arthroscopy procedure
- English speaking
Who cannot join
- Patient is less than 7 years of age or over 17 years of age
- Patient has cognitive impairments
- Patient had previous operations on the same lower extremity as the current knee arthroscopy
- Patient has a positive B-HCG (identified through urine or blood test)
- Patient does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19103
Ross Budziszewski, Masters of Science, 2154274619, rbud58@gmail.com
Aysha Hasan, MD, 2154275220, aysha.hasan@towerhealth.org
About this study
Official title: Defining the Optimal Location to Place Local Anesthetic for an Adductor Canal Block for Pediatric Knee Arthroscopy Patients
The aim of the current project is to address a gap in the existing literature related to optimal placement of local anesthetic for an adductor canal (AC) block. The current study seeks to examine whether placement of the local anesthetic in the AC for knee surgery is more effective at reducing post-operative pain following arthroscopic knee surgery compared to a control. Specifically, if the anesthetic is more beneficial than the control group, the research will determine which location is optimal by comparing groups that receive anesthetic in the midpoint of the thigh, the proximal end of the thigh, or the distal end of the thigh.
Read the detailed description
Although there has been an abundance of literature highlighting the efficacy of using regional blocks to decrease post-operative pain, the exact location of placement of local anesthetic for anesthetizing the nerves in the AC is unknown for optimal pain relief in patients undergoing knee surgery. The saphenous nerve consistently lies in the AC at various points of local anesthetic deposit, however there are many other nerves that lie in the canal that may branch off proximally or distally from the AC that are important to target in achieving optimal pain relief for patients undergoing knee arthroscopy.1-3 The AC is bounded in a triangular shape by the vastus medialis anterolaterally, the sartorius medially, and the adductor longus/adductor magnus posteriorly. The canal contains the deep femoral artery and the deep femoral vein. The saphenous nerve consistently lies within this canal, a significant sensory contributor to the knee.1-3 Other branches of the femoral nerve can also be found in the AC. The nerve to the vastus medialis (NVM) and the posterior branches of the obtruator nerve (PON) can also be found, although inconsistently, in the AC at various locations.4,5 These nerves are thought to innervate the knee as well and contribute to pain when missed during this block. The course of these nerves is unknown. While some surmise that the NVM branches proximally and the PON branches distally, there is no consensus on this.
Currently, an AC block is most often placed in the mid-thigh as measured by visual observation. The investigators seek to investigate where along the tract of the AC would be optimal to place local anesthetic to optimize analgesia on all nerves that innervate the knee without having motor loss as would occur with a femoral nerve block
- Conditions
- Knee Arthropathy
- Being tested
- Placement of an adductor canal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of an adductor canal nerve blockProcedure or surgery
An adductor canal nerve block will be placed in a patient undergoing a knee arthroscopy in 1 of 3 locations with local anesthetic or placebo (without location definition or local anesthetic) to assess optimal placement of local anesthetic, pain management and anxiety scores post operatively.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Saline will be placed in syringe instead of ropivicaine 0.2% and the nerve block will be placed in the adductor canal at the desired location by the anesthesiologist Receives: Procedure: Placement of an adductor canal nerve block |
| B | Active comparator | An adductor canal block will be placed with local anesthetic in the proximal 1/3 of the operative leg Receives: Procedure: Placement of an adductor canal nerve block |
| C | Active comparator | An adductor canal block will be placed with local anesthetic in the middle 1/3 of the operative leg Receives: Procedure: Placement of an adductor canal nerve block |
| D | Active comparator | An adductor canal block will be placed with local anesthetic in the distal 1/3 of the operative leg Receives: Procedure: Placement of an adductor canal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported pain as assessed by Wong-Baker FACES scale
Patient self-reported pain intensity following the procedure. The scale ranges from 0-10 (0 = no pain; 10 = extreme). Collected at two points: pre-and-post procedure.
Measured: 48 hours
Secondary outcomes (4)
Patient reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S)
Patient self-reported anxiety levels will be measured on a thermometer-style graphic, where the bottom (near the base) represents low anxiety and the top represents high levels of anxiety.
Measured: 48 hours
Parent reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S
Parent self-reported anxiety levels will be measured on a thermometer-style graphic, where the bottom (near the base) represents low anxiety and the top represents high levels of anxiety
Measured: 48 hours
Patient reported sensation through ice and pinprick
Patients will report sensation on their knee postoperatively by reponding if they can (yes) or cannot (no) feel a pinprick and piece of ice.
Measured: 48 hours
Usage of narcotic pain medication
The amount of narcotic pain medication that the patients utilize after their discharge will be documented as morphine milligram equivalents (e.g., MME).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Knee ArthropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysha Hasan, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298476
- Sponsor's protocol ID
- 1901006926
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
PubMed 28002228Bendtsen T.F., Lopez A.M., Clark T.B. (2018). Ultrasound-Guided Saphenous (Subsartorius/Adductor Canal) Nerve Block. NYSORA Continuing Medical Education. Retrieved from https://www.nysora.com/ultrasound-guided-saphenous-subsartoriusadductor-canal-nerve-block
Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
PubMed 27015545Quemby D. & McEwen A. (2014). Ultrasound Guided Adductor Canal Block (Saphenous Nerve Block). Anesthesia Tutorial of the Week. Retrieved from https://www.aagbi.org/sites/default/files/301%20Ultrasound%20Guided%20Adductor%20Canal%20(Saphenous%20Nerve)%20Block.pdf
Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.
PubMed 28937534Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
PubMed 24094126
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Optimal Location to Place Local Anesthetic for an Adductor Canal Block for Pediatric Knee Arthroscopy Patients
- ClinicalTrials.gov ID
- NCT04298476
- Acronym / sponsor ID
- 1901006926
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Mar 2020 (actual)
- 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.
The aim of the current project is to address a gap in the existing literature related to optimal placement of local anesthetic for an adductor canal (AC) block. The current study seeks to examine whether placement of the local anesthetic in the AC for knee surgery is more effective at reducing post-operative pain following arthroscopic knee surgery compared to a control. Specifically, if the anesthetic is more beneficial than the control group, the research will determine which location is optimal by comparing groups that receive anesthetic in the midpoint of the thigh, the proximal end of the thigh, or the distal end of the thigh.
Detailed description
Although there has been an abundance of literature highlighting the efficacy of using regional blocks to decrease post-operative pain, the exact location of placement of local anesthetic for anesthetizing the nerves in the AC is unknown for optimal pain relief in patients undergoing knee surgery. The saphenous nerve consistently lies in the AC at various points of local anesthetic deposit, however there are many other nerves that lie in the canal that may branch off proximally or distally from the AC that are important to target in achieving optimal pain relief for patients undergoing knee arthroscopy.1-3 The AC is bounded in a triangular shape by the vastus medialis anterolaterally, the sartorius medially, and the adductor longus/adductor magnus posteriorly. The canal contains the deep femoral artery and the deep femoral vein. The saphenous nerve consistently lies within this canal, a significant sensory contributor to the knee.1-3 Other branches of the femoral nerve can also be found in the AC. The nerve to the vastus medialis (NVM) and the posterior branches of the obtruator nerve (PON) can also be found, although inconsistently, in the AC at various locations.4,5 These nerves are thought to innervate the knee as well and contribute to pain when missed during this block. The course of these nerves is unknown. While some surmise that the NVM branches proximally and the PON branches distally, there is no consensus on this.
Currently, an AC block is most often placed in the mid-thigh as measured by visual observation. The investigators seek to investigate where along the tract of the AC would be optimal to place local anesthetic to optimize analgesia on all nerves that innervate the knee without having motor loss as would occur with a femoral nerve block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Procedure: Placement of an adductor canal nerve blockSaline will be placed in syringe instead of ropivicaine 0.2% and the nerve block will be placed in the adductor canal at the desired location by the anesthesiologist |
| B | Active comparator | Procedure: Placement of an adductor canal nerve blockAn adductor canal block will be placed with local anesthetic in the proximal 1/3 of the operative leg |
| C | Active comparator | Procedure: Placement of an adductor canal nerve blockAn adductor canal block will be placed with local anesthetic in the middle 1/3 of the operative leg |
| D | Active comparator | Procedure: Placement of an adductor canal nerve blockAn adductor canal block will be placed with local anesthetic in the distal 1/3 of the operative leg |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient is 7 to ≤ 17 years of age
- Patient at St. Christopher's Hospital for Children
- Receiving a knee arthroscopy procedure
- English speaking
Key exclusion criteria (5 listed)
- Patient is less than 7 years of age or over 17 years of age
- Patient has cognitive impairments
- Patient had previous operations on the same lower extremity as the current knee arthroscopy
- Patient has a positive B-HCG (identified through urine or blood test)
- Patient does not speak English
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 |
|---|---|---|
| Placement of an adductor canal nerve blockAn adductor canal nerve block will be placed in a patient undergoing a knee arthroscopy in 1 of 3 locations with local anesthetic or placebo (without location definition or local anesthetic) to assess optimal placement of local anesthetic, pain management and anxiety scores post operatively. | Procedure or surgery | A, B, C, D |
Primary outcome
Reported pain as assessed by Wong-Baker FACES scale
Time frame: 48 hours
Patient self-reported pain intensity following the procedure. The scale ranges from 0-10 (0 = no pain; 10 = extreme). Collected at two points: pre-and-post procedure.
4 secondary outcomes
Patient reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S)
Time frame: 48 hours
Parent reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S
Time frame: 48 hours
Patient reported sensation through ice and pinprick
Time frame: 48 hours
Usage of narcotic pain medication
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Background: PubMed 28002228Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
- BackgroundBendtsen T.F., Lopez A.M., Clark T.B. (2018). Ultrasound-Guided Saphenous (Subsartorius/Adductor Canal) Nerve Block. NYSORA Continuing Medical Education. Retrieved from https://www.nysora.com/ultrasound-guided-saphenous-subsartoriusadductor-canal-nerve-block
- Background: PubMed 27015545Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
- BackgroundQuemby D. & McEwen A. (2014). Ultrasound Guided Adductor Canal Block (Saphenous Nerve Block). Anesthesia Tutorial of the Week. Retrieved from https://www.aagbi.org/sites/default/files/301%20Ultrasound%20Guided%20Adductor%20Canal%20(Saphenous%20Nerve)%20Block.pdf
- Background: PubMed 28937534Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.
- Background: PubMed 24094126Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of an adductor canal nerve block in people with Knee Arthropathy, run by Drexel University 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported pain as assessed by Wong-Baker FACES scale (time frame: 48 hours). 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 NCT04298476, 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 6 Mar 2020.