NCT04298476

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

February 18, 2020

Last Update Submit

March 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours

Secondary Outcomes (4)

  • Patient reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S)

    48 hours

  • Parent reported anxiety as assessed by the Child's Anxiety Meter-State (CAM-S

    48 hours

  • Patient reported sensation through ice and pinprick

    48 hours

  • Usage of narcotic pain medication

    48 hours

Study Arms (4)

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

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

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

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

Procedure: Placement of an adductor canal nerve block

Interventions

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.

ABCD

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (6)

  • 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.

    PMID: 28002228BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 27015545BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28937534BACKGROUND
  • 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.

    PMID: 24094126BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Anesthesiologist

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 6, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations