Total Knee ArthroplastyNCT02799797
Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques
A study testing ultrasound guided long axis placement of adductor canal catheter, ultrasound guided short axis placement of adductor canal catheter and Philip CX 50 Ultrasound Scanner in people with Total Knee Arthroplasty and Analgesia, run by Cui Xulei at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Analgesia, Nerve Block
- What is being tested?
- ultrasound guided long axis placement of adductor canal catheter, ultrasound guided short axis placement of adductor canal catheter and Philip CX 50 Ultrasound Scanner
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to 18 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years
- Knee-arthroscopy
- Written consent
- ASA I-III
- BMI 19-35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Total Knee Arthroplasty, Analgesia, Nerve Block
- Being tested
- ultrasound guided long axis placement of adductor canal catheter, ultrasound guided short axis placement of adductor canal catheter, Philip CX 50 Ultrasound Scanner, PAJUNK Contiplex S Catheter, Ropivocaine
- Keywords
- adductor canal block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided long axis placement of adductor canal catheterProcedure or surgery
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
ultrasound guided short axis placement of adductor canal catheterProcedure or surgery
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
Philip CX 50 Ultrasound ScannerDevice
The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
PAJUNK Contiplex S CatheterDevice
RopivocaineDrug
0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
rescue sulfentanil given postoperatively as PICADrug
bolus: 2mg, lock time: 10min, 1h limitation: 8mg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
| 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 Receives: Procedure: ultrasound guided long 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the strength of quadriceps femoris
strength of quadriceps femoris measured on a Lovett muscle strength rating-scale within 48 hours after surgery
Measured: within 48hours after surgery
Secondary outcomes (8)
postoperative nausea and vomiting score
Rating-scale 0-3 SAX-group vs. LAX-group
Measured: 0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
ambulation time
SAX-group vs. LAX-group
Measured: within the 7 days after surgery
quality of recovery
use the self-assessment 11item QoR scale to assess the patient's recovery quality,SAX-group vs. LAX-group
Measured: 3days and 7days after surgery
complications
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
Measured: within the 7 days after surgery
the strength of quadriceps femoris
SAX-group vs. LAX-group
Measured: 0,2,4,8,24,48 hours postoperative
Pain-score (VAS), patient at rest
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
Measured: 0,2,4,8,24,48 hours postoperative
Pain-score (VAS), motion pain
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
Measured: 0,2,4,8,24,48 hours postoperative
sulfentanil consumption
record the amount（ml) of sulfentanil used
Measured: 0,2,4,8,24,48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion3 Feb 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cui Xulei
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Consulting Center
- Responsible party
- Sponsor-investigator, Cui Xulei, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799797
- Sponsor's protocol ID
- cuixulei1
- Status last verified
- Apr 2019
- First submitted
- 7 Jun 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques
- ClinicalTrials.gov ID
- NCT02799797
- Acronym / sponsor ID
- cuixulei1
- Conditions
- Total Knee Arthroplasty, Analgesia, Nerve Block
- Keywords
- adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Collaborators
- Medical Consulting Center
- Study start
- Jul 2016 (actual)
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short axis (SAX) placement of adductor canal catheters | Active comparator | 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 PICAProcedure: 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 |
| long axis (LAX) placement of adductor canal catheters | Experimental | Procedure: ultrasound guided long 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 PICAProcedure: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years
- Knee-arthroscopy
- Written consent
- ASA I-III
- BMI 19-35
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided long axis placement of adductor canal catheterThe 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 | Procedure or surgery | long axis (LAX) placement of adductor canal catheters |
| ultrasound guided short axis placement of adductor canal catheterThe 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 | Procedure or surgery | short axis (SAX) placement of adductor canal catheters |
| Philip CX 50 Ultrasound ScannerThe linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning | Device | long axis (LAX) placement of adductor canal catheters, short axis (SAX) placement of adductor canal catheters |
| PAJUNK Contiplex S Catheter | Device | long axis (LAX) placement of adductor canal catheters, short axis (SAX) placement of adductor canal catheters |
| Ropivocaine0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose. | Drug | long axis (LAX) placement of adductor canal catheters, short axis (SAX) placement of adductor canal catheters |
| rescue sulfentanil given postoperatively as PICAbolus: 2mg, lock time: 10min, 1h limitation: 8mg | Drug | long axis (LAX) placement of adductor canal catheters, short axis (SAX) placement of adductor canal catheters |
Primary outcome
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
8 secondary outcomes
postoperative nausea and vomiting score
Time frame: 0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
ambulation time
Time frame: within the 7 days after surgery
quality of recovery
Time frame: 3days and 7days after surgery
complications
Time frame: within the 7 days after surgery
the strength of quadriceps femoris
Time frame: 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 (VAS), motion pain
Time frame: 0,2,4,8,24,48 hours postoperative
sulfentanil consumption
Time frame: 0,2,4,8,24,48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguang Huang, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided long axis placement of adductor canal catheter, ultrasound guided short axis placement of adductor canal catheter and Philip CX 50 Ultrasound Scanner in people with Total Knee Arthroplasty and Analgesia, run by Cui Xulei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the strength of quadriceps femoris (time frame: within 48hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.