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Defining the Optimal Location to Place an Adductor Canal Block

Primary Purpose

Knee Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement of an adductor canal nerve block
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient is 7 to ≤ 17 years of age
  • Patient at St. Christopher's Hospital for Children
  • Receiving a knee arthroscopy procedure
  • English speaking

Exclusion Criteria:

  • 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

Sites / Locations

  • St. Christopher's Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

D

Arm Description

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

An adductor canal block will be placed with local anesthetic in the proximal 1/3 of the operative leg

An adductor canal block will be placed with local anesthetic in the middle 1/3 of the operative leg

An adductor canal block will be placed with local anesthetic in the distal 1/3 of the operative leg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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).

Full Information

First Posted
February 18, 2020
Last Updated
March 4, 2020
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT04298476
Brief Title
Defining the Optimal Location to Place an Adductor Canal Block
Official Title
Defining the Optimal Location to Place Local Anesthetic for an Adductor Canal Block for Pediatric Knee Arthroscopy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
B
Arm Type
Active Comparator
Arm Description
An adductor canal block will be placed with local anesthetic in the proximal 1/3 of the operative leg
Arm Title
C
Arm Type
Active Comparator
Arm Description
An adductor canal block will be placed with local anesthetic in the middle 1/3 of the operative leg
Arm Title
D
Arm Type
Active Comparator
Arm Description
An adductor canal block will be placed with local anesthetic in the distal 1/3 of the operative leg
Intervention Type
Procedure
Intervention Name(s)
Placement of an adductor canal nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reported pain as assessed by Wong-Baker FACES scale
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Patient reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S)
Description
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.
Time Frame
48 hours
Title
Parent reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S
Description
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
Time Frame
48 hours
Title
Patient reported sensation through ice and pinprick
Description
Patients will report sensation on their knee postoperatively by reponding if they can (yes) or cannot (no) feel a pinprick and piece of ice.
Time Frame
48 hours
Title
Usage of narcotic pain medication
Description
The amount of narcotic pain medication that the patients utilize after their discharge will be documented as morphine milligram equivalents (e.g., MME).
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient is 7 to ≤ 17 years of age Patient at St. Christopher's Hospital for Children Receiving a knee arthroscopy procedure English speaking Exclusion Criteria: 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
Facility Information:
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ross Budziszewski, Masters of Science
Phone
2154274619
Email
rbud58@gmail.com
First Name & Middle Initial & Last Name & Degree
Aysha Hasan, MD
Phone
2154275220
Email
aysha.hasan@towerhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28002228
Citation
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.
Results Reference
background
Citation
Bendtsen 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
Results Reference
background
PubMed Identifier
27015545
Citation
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.
Results Reference
background
Citation
Quemby 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
Results Reference
background
PubMed Identifier
28937534
Citation
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.
Results Reference
background
PubMed Identifier
24094126
Citation
Ersig 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.
Results Reference
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Defining the Optimal Location to Place an Adductor Canal Block

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