Arthroplasty, Replacement, KneeNCT05202730
Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty
A study testing New local anesthesia injection site and new local anesthetic drug formulation. in people with Arthroplasty, Replacement, Knee and Analgesia, run by Diwuweilong at 1 site in China.
Trial summary
Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Analgesia
- What is being tested?
- New local anesthesia injection site and new local anesthetic drug formulation.
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2021to 10 Dec 2023
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;
- 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;
- 3. There is no contraindications to combined spinal-epidural anesthesia;
- 4. Agree to accept this trial and sign an informed consent form.
Who cannot join
- 1. Allergic to test drugs;
- 2. Abnormal liver, kidney or heart function;
- 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;
- 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
- 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
- 6. Cannot communicate with researchers normally.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Orthopedics, Xijing Hospital, The Air Force Medical University
Xi’an, Shanxi, 710032
Weilong Diwu, M.M., +8618792498312, diwuweilong@sohu.com
About this study
Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.
- Conditions
- Arthroplasty, Replacement, Knee, Analgesia
- Being tested
- New local anesthesia injection site and new local anesthetic drug formulation.
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New local anesthesia injection site and new local anesthetic drug formulation.Procedure or surgery
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.
| Study group | Role | What they receive |
|---|---|---|
| Traditional injection site and traditional local anesthetic formulation | Other | Not described Receives: Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| Traditional injection site and new local anesthetic formulation | Experimental | Not described Receives: Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| New injection site and traditional local anesthetic formulation | Experimental | Not described Receives: Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| New injection site and new local anesthetic formulation | Experimental | Not described Receives: Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the pain score before and after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start25 Dec 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
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 Arthroplasty, Replacement, KneeStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diwuweilong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diwuweilong, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202730
- Sponsor's protocol ID
- KY20212115-F-2
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diwu W, Tang W, Yan M, Ma W, Xu H, Sun Q, Han Y, Wang Y, Wang C, Zhang D, Bi L, Yang M. Efficacy of Peripheral Cutaneous Nerve (PCN) on postoperative pain and functional outcome after total knee arthroplasty: a single-blind, randomized controlled clinical trial". BMC Anesthesiol. 2025 Jul 1;25(1):322. doi: 10.1186/s12871-025-03182-z.
PubMed 40597686
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05202730
- Acronym / sponsor ID
- KY20212115-F-2
- Conditions
- Arthroplasty, Replacement, Knee, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- DiwuweilongUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 21 Jan 2022 (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.
Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional injection site and traditional local anesthetic formulation | Other | Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| Traditional injection site and new local anesthetic formulation | Experimental | Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| New injection site and traditional local anesthetic formulation | Experimental | Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
| New injection site and new local anesthetic formulation | Experimental | Procedure: New local anesthesia injection site and new local anesthetic drug formulation. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;
- 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;
- 3. There is no contraindications to combined spinal-epidural anesthesia;
- 4. Agree to accept this trial and sign an informed consent form.
Key exclusion criteria (6 listed)
- 1. Allergic to test drugs;
- 2. Abnormal liver, kidney or heart function;
- 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;
- 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
- 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
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 |
|---|---|---|
| New local anesthesia injection site and new local anesthetic drug formulation.The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide. | Procedure or surgery | New injection site and new local anesthetic formulation, New injection site and traditional local anesthetic formulation, Traditional injection site and new local anesthetic formulation, Traditional injection site and traditional local anesthetic formulation |
Primary outcome
Change of the pain score before and after surgery
Time frame: pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery.
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 40597686Diwu W, Tang W, Yan M, Ma W, Xu H, Sun Q, Han Y, Wang Y, Wang C, Zhang D, Bi L, Yang M. Efficacy of Peripheral Cutaneous Nerve (PCN) on postoperative pain and functional outcome after total knee arthroplasty: a single-blind, randomized controlled clinical trial". BMC Anesthesiol. 2025 Jul 1;25(1):322. doi: 10.1186/s12871-025-03182-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New local anesthesia injection site and new local anesthetic drug formulation. in people with Arthroplasty, Replacement, Knee and Analgesia, run by Diwuweilong 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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weilong Diwu, M.M. (+8618792498312, diwuweilong@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the pain score before and after surgery (time frame: pre-operation, 6hours after surgery, 24hours after surgery, 48 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 NCT05202730, 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 6 Mar 2023.