- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942133
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
December 29, 2019 updated by: Cui Xulei, Peking Union Medical College Hospital
Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Block at the Entrance and Middle of the Canal
This study compares the tow technique of continues adductor canal block for total knee replacement surgery.
Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal.
Study Overview
Status
Completed
Conditions
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
-
-
-
Beijing, China
- Peking Union Medical College Hospital
-
-
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 |
---|---|
Experimental: entrance placement of adductor canal catheter
|
Ultrasound probe is placed at the entrance of the adductor canal in short axis ,insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the entrance of the canal
|
Experimental: middle point placement of adductor canal catheter
|
Ultrasound probe is placed at the middle of the adductor canal in long axis with the caphelad end of the probe aligned with the entrance of the canal.
insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the middle of the canal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cumulative sulfentanil consumption at 24 hours after surgery
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the strength of quadriceps femoris
Time Frame: 0,2,4,8,24,48 hours postoperatively
|
Quadriceps strength was assessed on a 0-5 scale as per the Medical Research Council Scale quadriceps motor strength(0 = no voluntary contraction possible, 1 = muscle flicker, but no movement of limb, 2 = active movement only with gravity eliminated, 3 = movement against gravity but without resistance, 4 = movement possible against some resistance and 5 = normal motor strength against resistance)
|
0,2,4,8,24,48 hours postoperatively
|
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Time Frame: at 0,2,4,8,24,48 hours postoperatively
|
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
|
at 0,2,4,8,24,48 hours postoperatively
|
The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)
Time Frame: at 0,2,4,8,24,48 hours postoperatively
|
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
|
at 0,2,4,8,24,48 hours postoperatively
|
incidence of postoperative nausea and vomiting (PONV)
Time Frame: within 48 hours after surgery
|
within 48 hours after surgery
|
|
Patient satisfaction with anesthesia
Time Frame: within 5th day after surgery
|
Patient satisfaction with anesthesia was assessed using a 5-point scale (5, very satisfied; 4, satisfied; 3, neither satisfied nor dissatisfied; 2, dissatisfied; 1, very dissatisfied)
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within 5th day after surgery
|
complications
Time Frame: within 3days after surgery
|
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
|
within 3days after surgery
|
cumulative sulfentanil consumption at other time points after surgery
Time Frame: 2,4,8,48 hours postoperatively
|
2,4,8,48 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 11, 2019
Primary Completion (Actual)
December 8, 2019
Study Completion (Actual)
December 16, 2019
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 29, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CXL1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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