NCT02563990

Brief Summary

This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

September 25, 2015

Results QC Date

December 11, 2019

Last Update Submit

January 6, 2020

Conditions

Orthopedic DisordersInjury of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Spread of Injectate

    Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.

    Immediate post-procedure on day 1

Secondary Outcomes (8)

  • Number of Events of Femoral Nerve Block 30 Minutes After Block Placement

    post-procedure and postoperative on day 1

  • Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement

    post-procedure and postoperative on day 1

  • Postoperative Pain Scores (Numeric Rating Scale, 0-10)

    postoperative on day 1

  • Postoperative Physical Therapy Milestone Achievement

    postoperative week 1

  • Postoperative Physical Therapy Milestone Achievement

    postoperative week 2

  • +3 more secondary outcomes

Study Arms (2)

High Pressure

EXPERIMENTAL

High pressure injection of Ropivacaine local anesthetic at greater than 20 psi

Procedure: High Pressure Injection

Low Pressure

ACTIVE COMPARATOR

Low pressure injection of Ropivacaine local anesthetic at less than 15 psi

Procedure: Low Pressure Injection

Interventions

High Pressure InjectionPROCEDURE

Adductor canal block performed at greater than 20 psi injection pressure

High Pressure
Low Pressure InjectionPROCEDURE

Adductor canal block performed at less than 15 psi injection pressure

Low Pressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned general anesthetic.
  • American Society of Anesthesia classes I, II, or III.
  • Patients aged 18-65.
  • English-speaking patients.

You may not qualify if:

  • ASA classes IV and V.
  • Patients younger than 18 or older than 65.
  • Contraindication to regional anesthesia (coagulopathy, patient refusal).
  • Allergy to local anesthetic or other study medications.
  • BMI \> 35 kg/m2.
  • Chronic opioid use (daily or almost daily use for \> 3 months).
  • Active illicit drug use.
  • Additional surgical site other than the limb for adductor canal block.
  • Pregnancy.
  • Preexisting neuropathy in the operative limb.
  • Inability to communicate to investigators or hospital staff.
  • Inability to speak or understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Limitations and Caveats

Trial was terminated early due to inability to recruit additional subjects after the participating surgeons were staffed at a different hospital and no replacement surgical service was established.

Results Point of Contact

Title
Andres Missair
Organization
University of Miami
amissair@miami.edu
3055857037

Study Officials

  • Andres Missair, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 30, 2015

Study Start

December 3, 2015

Primary Completion

November 9, 2016

Study Completion

December 9, 2016

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)