- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799797
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
Completed
Conditions
Intervention / Treatment
- Procedure: ultrasound guided short axis placement of adductor canal catheter
- Device: Philip CX 50 Ultrasound Scanner
- Device: PAJUNK Contiplex S Catheter
- Drug: Ropivocaine
- Drug: rescue sulfentanil given postoperatively as PICA
- Procedure: ultrasound guided long axis placement of adductor canal catheter
Study Type
Interventional
Enrollment (Actual)
62
Phase
- 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
-
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Beijing
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Beijing, Beijing, China, 100730
- Xulei CUI
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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
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 |
Intervention / Treatment |
---|---|
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
|
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
The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
0.2% ropivacaine 10ml is given as loading dose.
Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
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
|
The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
0.2% ropivacaine 10ml is given as loading dose.
Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
bolus: 2mg, lock time: 10min, 1h limitation: 8mg
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the strength of quadriceps femoris
Time Frame: within 48hours after surgery
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strength of quadriceps femoris measured on a Lovett muscle strength rating-scale within 48 hours after surgery
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within 48hours after surgery
|
Secondary Outcome Measures
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
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Rating-scale 0-3 SAX-group vs. LAX-group
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0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
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ambulation time
Time Frame: within the 7 days after surgery
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SAX-group vs. LAX-group
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within the 7 days after surgery
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quality of recovery
Time Frame: 3days and 7days after surgery
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use the self-assessment 11item QoR scale to assess the patient's recovery quality,SAX-group vs. LAX-group
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3days and 7days after surgery
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complications
Time Frame: within the 7 days after surgery
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Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
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within the 7 days after surgery
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the strength of quadriceps femoris
Time Frame: 0,2,4,8,24,48 hours postoperative
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SAX-group vs. LAX-group
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0,2,4,8,24,48 hours postoperative
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Pain-score (VAS), patient at rest
Time Frame: 0,2,4,8,24,48 hours postoperative
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Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
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0,2,4,8,24,48 hours postoperative
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Pain-score (VAS), motion pain
Time Frame: 0,2,4,8,24,48 hours postoperative
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Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
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0,2,4,8,24,48 hours postoperative
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sulfentanil consumption
Time Frame: 0,2,4,8,24,48 hours postoperative
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record the amount(ml) of sulfentanil used
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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
Collaborators
Investigators
- 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)
July 1, 2016
Primary Completion (Actual)
February 3, 2018
Study Completion (Actual)
April 18, 2018
Study Registration Dates
First Submitted
June 7, 2016
First Submitted That Met QC Criteria
June 11, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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