Total Knee ArthroplastyNCT03942133
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
A study testing ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal and ultrasound-guided long-axis placement of catheter at the middle of the adductor canal in people with Total Knee Arthroplasty and Analgesia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. 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 short-axis placement of catheter at the entrance of the adductor canal and ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2019to 16 Dec 2019
- 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
Official title: 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.
- Conditions
- Total Knee Arthroplasty, Analgesia, Nerve Block
- Being tested
- ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal, ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
- 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 short-axis placement of catheter at the entrance of the adductor canalProcedure or surgery
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
ultrasound-guided long-axis placement of catheter at the middle of the adductor canalProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| entrance placement of adductor canal catheter | Experimental | Not described Receives: Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal |
| middle point placement of adductor canal catheter | Experimental | Not described Receives: Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative sulfentanil consumption at 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (7)
the strength of quadriceps femoris
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)
Measured: 0,2,4,8,24,48 hours postoperatively
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Measured: 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)
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Measured: at 0,2,4,8,24,48 hours postoperatively
incidence of postoperative nausea and vomiting (PONV)
Measured: within 48 hours after surgery
Patient satisfaction with anesthesia
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)
Measured: within 5th day after surgery
complications
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
Measured: within 3days after surgery
cumulative sulfentanil consumption at other time points after surgery
Measured: 2,4,8,48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start11 May 2019
- Primary completion8 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942133
- Sponsor's protocol ID
- CXL1
- Status last verified
- Dec 2019
- First submitted
- 6 May 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fei Y, Cui X, Chen S, Peng H, Feng B, Qian W, Lin J, Weng X, Huang Y. Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2020 Oct 9;20(1):260. doi: 10.1186/s12871-020-01165-w.
PubMed 33036554
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. 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 Block at the Entrance and Middle of the Canal
- ClinicalTrials.gov ID
- NCT03942133
- Acronym / sponsor ID
- CXL1
- Conditions
- Total Knee Arthroplasty, Analgesia, Nerve Block
- Keywords
- adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 11 May 2019 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 8 May 2019 (actual)
- 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| entrance placement of adductor canal catheter | Experimental | Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal |
| middle point placement of adductor canal catheter | Experimental | Procedure: ultrasound-guided long-axis placement of catheter at the middle of the 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 short-axis placement of catheter at the entrance of the adductor canalUltrasound 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 | Procedure or surgery | entrance placement of adductor canal catheter |
| ultrasound-guided long-axis placement of catheter at the middle of the adductor canalUltrasound 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 | Procedure or surgery | middle point placement of adductor canal catheter |
Primary outcome
cumulative sulfentanil consumption at 24 hours after surgery
Time frame: 24 hours after surgery
7 secondary outcomes
the strength of quadriceps femoris
Time frame: 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
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
incidence of postoperative nausea and vomiting (PONV)
Time frame: within 48 hours after surgery
Patient satisfaction with anesthesia
Time frame: within 5th day after surgery
complications
Time frame: within 3days after surgery
cumulative sulfentanil consumption at other time points after surgery
Time frame: 2,4,8,48 hours postoperatively
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 2 Jan 2020.
- Derived from this study: PubMed 33036554Fei Y, Cui X, Chen S, Peng H, Feng B, Qian W, Lin J, Weng X, Huang Y. Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2020 Oct 9;20(1):260. doi: 10.1186/s12871-020-01165-w.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 short-axis placement of catheter at the entrance of the adductor canal and ultrasound-guided long-axis placement of catheter at the middle of the adductor canal in people with Total Knee Arthroplasty and Analgesia, run by Peking Union Medical College Hospital 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 2 Jan 2020. 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?
cumulative sulfentanil consumption at 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942133, which also lists 1 linked publication.
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 2 Jan 2020.