NCT02799797

Brief Summary

This study compares the long-axis and short-axis technique of continues adductor canal block for total knee replacement surgery. Half participants will receive long-axis catheterization, while the other half will receive short-axis catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

June 7, 2016

Last Update Submit

April 15, 2019

Conditions

Keywords

adductor canal block

Outcome Measures

Primary Outcomes (1)

  • the strength of quadriceps femoris

    strength of quadriceps femoris measured on a Lovett muscle strength rating-scale within 48 hours after surgery

    within 48hours after surgery

Secondary Outcomes (8)

  • postoperative nausea and vomiting score

    0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative

  • ambulation time

    within the 7 days after surgery

  • quality of recovery

    3days and 7days after surgery

  • complications

    within the 7 days after surgery

  • the strength of quadriceps femoris

    0,2,4,8,24,48 hours postoperative

  • +3 more secondary outcomes

Study Arms (2)

short axis (SAX) placement of adductor canal catheters

ACTIVE COMPARATOR

Procedure: Ultrasound guided short axis (SAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a PAJUNK Contiplex S catheter along the short axis of the middle part of adductor canal

Procedure: ultrasound guided short axis placement of adductor canal catheterDevice: Philip CX 50 Ultrasound ScannerDevice: PAJUNK Contiplex S CatheterDrug: RopivocaineDrug: rescue sulfentanil given postoperatively as PICA

long axis (LAX) placement of adductor canal catheters

EXPERIMENTAL

Procedure: Ultrasound guided long axis (LAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a catheter along the long axis of the middle part of adductor canal

Procedure: ultrasound guided long axis placement of adductor canal catheterDevice: Philip CX 50 Ultrasound ScannerDevice: PAJUNK Contiplex S CatheterDrug: RopivocaineDrug: rescue sulfentanil given postoperatively as PICA

Interventions

The long axis of the ultrasound probe is placed parallel to the long axis of the adductor canal while scanning, and the catheter is placed along the long axis of the canal using an in-plane approach

long axis (LAX) placement of adductor canal catheters

The long axis of the ultrasound probe is placed vertical to the long axis of the adductor canal while scanning, and the catheter is placed along the short axis of the canal using an in-plane approach

short axis (SAX) placement of adductor canal catheters

The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning

long axis (LAX) placement of adductor canal cathetersshort axis (SAX) placement of adductor canal catheters
long axis (LAX) placement of adductor canal cathetersshort axis (SAX) placement of adductor canal catheters

0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.

long axis (LAX) placement of adductor canal cathetersshort axis (SAX) placement of adductor canal catheters

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

long axis (LAX) placement of adductor canal cathetersshort axis (SAX) placement of adductor canal catheters

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Knee-arthroscopy
  • Written consent
  • ASA I-III
  • BMI 19-35

You may not qualify if:

  • Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
  • coagulopathy or on anticoagulant medication
  • Allergic reactions toward drugs used in the trial
  • History of substance abuse
  • Infection at injection site
  • Can not be mobilised to 5 meters of walk pre-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xulei CUI

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuguang Huang, MD

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 15, 2016

Study Start

July 1, 2016

Primary Completion

February 3, 2018

Study Completion

April 18, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations