Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques

April 15, 2019 updated by: Cui Xulei
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Xulei CUI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years
  • Knee-arthroscopy
  • Written consent
  • ASA I-III
  • BMI 19-35

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: short axis (SAX) placement of adductor canal catheters
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 catheter
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
Device: Philip CX 50 Ultrasound Scanner
The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter
Drug: Ropivocaine
0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
Drug: rescue sulfentanil given postoperatively as PICA
bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Experimental: long axis (LAX) placement of adductor canal catheters
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
Device: Philip CX 50 Ultrasound Scanner
The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter
Drug: Ropivocaine
0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
Drug: rescue sulfentanil given postoperatively as PICA
bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Procedure: ultrasound guided long axis placement of adductor canal catheter
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the strength of quadriceps femoris
Time Frame: within 48hours after surgery
strength of quadriceps femoris measured on a Lovett muscle strength rating-scale within 48 hours after surgery
within 48hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative nausea and vomiting score
Time Frame: 0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
Rating-scale 0-3 SAX-group vs. LAX-group
0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
ambulation time
Time Frame: within the 7 days after surgery
SAX-group vs. LAX-group
within the 7 days after surgery
quality of recovery
Time Frame: 3days and 7days after surgery
use the self-assessment 11item QoR scale to assess the patient's recovery quality,SAX-group vs. LAX-group
3days and 7days after surgery
complications
Time Frame: within the 7 days after surgery
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
within the 7 days after surgery
the strength of quadriceps femoris
Time Frame: 0,2,4,8,24,48 hours postoperative
SAX-group vs. LAX-group
0,2,4,8,24,48 hours postoperative
Pain-score (VAS), patient at rest
Time Frame: 0,2,4,8,24,48 hours postoperative
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
0,2,4,8,24,48 hours postoperative
Pain-score (VAS), motion pain
Time Frame: 0,2,4,8,24,48 hours postoperative
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
0,2,4,8,24,48 hours postoperative
sulfentanil consumption
Time Frame: 0,2,4,8,24,48 hours postoperative
record the amount（ml) of sulfentanil used
0,2,4,8,24,48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cui Xulei

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Consulting Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuguang Huang, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cuixulei1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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