Total Knee ArthroplastyNCT06600815
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
A study testing preemptive stepwise infiltration anaesthesia(PSIA) and postoperative local infiltration analgesia(PLIA) in people with Total Knee Arthroplasty and Pain Management, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). Eligible patients will be included in this study after signing the informed consent form. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Pain Management
- What is being tested?
- preemptive stepwise infiltration anaesthesia(PSIA) and postoperative local infiltration analgesia(PLIA)
- 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
- 110 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for inclusion:
- Clinical diagnosis of primary unilateral knee osteoarthritis (KOA), confirmed by imaging as KOA (Kellgren-Lawrence score ≥2). The patient was scheduled for initial unilateral total knee arthroplasty (TKA) at our hospital.
- Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the evaluation criteria.
- Participants aged 18 years or older, both male and female.
- Ability to provide informed consent and sign a written informed consent form.
- The ability to comprehend the research requirements and willingness to cooperate with the study instructions.
Who cannot join
- Patients will be excluded if they meet any of the following criteria:
- Previous knee surgery on the operative knee or a history of infection in the operative knee.
- Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis).
- Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30° and the use of unconventional arthroplasty components due to complex joint pathology [e.g., restrictive prostheses]).
- Allergy to the investigational drug.
- The presence of neuromuscular dysfunction on the operative side.
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- Dependence on anaesthesia drugs (defined as the use of opioid or local anaesthetic drugs exceeding 100 mg of morphine equivalents per week to control preoperative pain for more than 3 months).
- Poor overall health conditions, including but not limited to a glycated haemoglobin level exceeding 12%; blood pressure exceeding 170/110 mmHg; myocardial infarction, stroke, transient ischaemic attack, acute congestive heart failure, or any acute coronary events within the past 6 months; severe hepatic or renal dysfunction; and pregnancy or lactation.
- Concurrent participation in clinical trials other than this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Fang, Vice directors, 9738006@qq.com
About this study
Official title: Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). Eligible patients will be included in this study after signing the informed consent form. Before TKA, the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia (PSIA) group or a postoperative local infiltration analgesia (PLIA) group and administered different pain management protocols during surgery. Clinical evaluation will be conducted at baseline, before surgery, and at 6, 12, 24, 48, and 72 hours postoperatively, as well as during follow-up visits at 3 weeks, 6 weeks and 6 months postoperatively. All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6, 12, 24, 48, 72, and 96 weeks later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA.
Read the detailed description
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). This study aims to recruit 110 patients across a single centre over 1 year. Eligible patients will be included in this study after signing the informed consent form. Before TKA, the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia (PSIA) group or a postoperative local infiltration analgesia (PLIA) group and administered different pain management protocols during surgery. Clinical evaluation will be conducted at baseline, before surgery, and at 6, 12, 24, 48, and 72 hours postoperatively, as well as during follow-up visits at 3 weeks, 6 weeks and 6 months postoperatively. The primary outcomes are the amount of morphine consumed within 0-24 hours postsurgery and the visual analogue scale (VAS) score postsurgery. Secondary outcomes include the time to first rescue analgesia, total morphine consumption during hospitalization, postoperative joint function (measured by the Hospital for Special Surgery [HSS] score and knee joint range of motion [ROM]), intraoperative bleeding and serological indicators. All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6h, 12h, 24h, 48h, 72h, 3 weeks, 6 weeks and 6 months later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA. Statistical analyses utilizing regression models and survival analysis will be conducted to assess the relationships between the pain management method and postoperative pain and efficacy.
- Conditions
- Total Knee Arthroplasty, Pain Management
- Being tested
- preemptive stepwise infiltration anaesthesia(PSIA), postoperative local infiltration analgesia(PLIA)
- Keywords
- Total knee arthroplasty, Pain management, Anaesthesia in orthopaedics
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive stepwise infiltration anaesthesia(PSIA)Procedure or surgery
For PSIA patients, the anaesthetic is administered in stages. Initially, CA is injected at the incision site before the medial parapatellar incision. Following skin incision, more CA is injected into the subcutaneous tissue. After exposing the fascial layer and joint capsule, CA is used around the patellar tendon, and then CB is injected into the joint capsule and surrounding muscles. Additional CB is applied to the synovium and soft tissues after the joint cavity is opened, and more is used in the posterior joint capsule after bone resection.
postoperative local infiltration analgesia(PLIA)Procedure or surgery
Before standardized TKA and implantation of the prosthesis, 30-40 mL of CB will be used to infiltrate the synovium and whole joint capsule. Subsequently, the joint cavity, subcutaneous tissue, and skin will be closed layer by layer using routine procedures. After the skin is closed, 30-40 mL of CA will be injected into the skin and subcutaneous tissue.
| Study group | Role | What they receive |
|---|---|---|
| preemptive stepwise infiltration anaesthesia(PSIA) group | Experimental | Drugs：A cocktail of anaesthetics (30 mg of ropivacaine, 0.3 mg of adrenaline) will be prepared, diluted with normal saline to 120 mL, and divided into two equal parts(Cocktail A[CA] and Cocktail B[CB]), with CB containing 8 mg of added betamethasone (each 1 ml of the compound contains 5 mg betamethasone dipropionate [calculated as betamethasone] and 2 mg of betamethasone sodium phosphate [calculated as betamethasone]). Receives: Procedure: preemptive stepwise infiltration anaesthesia(PSIA) |
| postoperative local infiltration analgesia(PLIA) group | Active comparator | Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group. Receives: Procedure: postoperative local infiltration analgesia(PLIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption within the first 24 hours
Postoperative morphine consumption within the first 24 hours includes both routine analgesia and rescue analgesia, which will be converted to oral morphine equivalents (OMEs)
Measured: the first 24 hours after TKA
. Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months
VAS scores are the most commonly used indicator for assessing the intensity of patient pain (15). The scale ranges from "0" to "10", where "0" indicates no pain and "10" represents the most severe pain that is unbearable. Patients will rate their pain based on subjective perceptions. In this trial, VAS scores will be recorded once before TKA. The VAS scores will be assessed separately for the resting and flexion states. If the patient's hospitalization period is shorter than 72 hours, the VAS score at discharge will be recorded instead of that at 72 hours. Studies have shown that some patients still experience joint pain six months after TKA. The VAS scores of patients at 6 months after TKA will be evaluated. A VAS score of 4 or above is defined as "chronic persistent pain after TKA." The results will be used to evaluate whether PSIA can reduce pain after TKA.
Measured: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA
Secondary outcomes (15)
Postoperative time to first rescue analgesia
Rescue analgesia will be initiated when the patient reports local knee joint pain on the operative side with a VAS score > 4. The specific steps will be implemented as described previously. The time to rescue analgesia will be recorded.
Measured: up to 3 days
Total morphine consumption during hospitalization
It will be converted to total morphine equivalents and will include both the postoperative routine pain management regimen and rescue analgesia.
Measured: through study completion, an average of 6 months
The Hospital for Special Surgery Knee Score (HSS)
The Hospital for Special Surgery Knee Score (HSS) is a patient-reported questionnaire specific to the knee joint, with a total score of 100 points. It comprises six scoring components: pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee deformity (10 points) and stability (10 points). Additional points are deducted for the use of assistive devices, extension lag and varus deformity: up to 3 points for assistive device use, up to 5 points for extension lag and 1 point deducted for every 5 degrees of varus deformity. The scores are classified as follows: ≥ 85 as "Excellent", 70-84 as "Good", 60-69 as "Fair", and < 60 as "Poor". The HSS score is widely praised for its perceived ease of use and quick recording and has been shown to be an effective and reliable measure for assessing the efficacy of TKA.
Measured: 3 weeks, 6 weeks and 6 months postoperatively
Range of motion (ROM)
The range of motion (ROM) will be measured with a protractor thrice daily at 6-hour intervals, and the best value on each day will be used in the analysis. The range of motion (ROM) is from 0 to 180 degrees. The larger the angle, the more satisfactory the recovery of joint function.
Measured: 3 weeks, 6 weeks and 6 months postoperatively
Direct intraoperative bleeding
Intraoperative bleeding will be recorded directly by anesthesiologists (mL).
Measured: 24 hours postoperatively
Indirect intraoperative bleeding
Intraoperative bleeding will be estimated by subtracting the preoperative hemoglobin level from the hemoglobin level measured 24 hours postoperatively.
Measured: 24 hours postoperatively
Complete blood count
A complete blood count (CBC) can reflect the patient's postoperative inflammatory status. It measures various components of the blood, including white blood cells, red blood cells, and platelets, which can indicate the presence of inflammation or infection. An elevated white blood cell count, for example, is often associated with an inflammatory response.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
C-reactive protein (CRP)
C-reactive protein (CRP) can reflect the patient's postoperative inflammatory status.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) can reflect the patient's postoperative inflammatory status.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) can reflect the patient's postoperative inflammatory status.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Total bilirubin (TB)
Total bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Derect bilirubin (DB)
Derect bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Aspartate aminotransferase (AST)
Aspartate aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Alanine aminotransferase (ALT)
Alanine aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Creatinine (Cr)
Creatinine will be used to evaluate the impacts of surgical trauma and medications on patients.
Measured: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial employs a random allocation method. A randomization table will be generated using SPSS 26.0 software. Treatment groups will be selected based on patients' random numbers, ensuring that this clinical institution stratifies the subjects into a PSIA group and a PLIA group at a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Wenming Zhang, MD, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600815
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU|2024]576
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06600815
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU|2024]576
- Conditions
- Total Knee Arthroplasty, Pain Management
- Keywords
- Total knee arthroplasty, Pain management, Anaesthesia in orthopaedics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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 is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). Eligible patients will be included in this study after signing the informed consent form. Before TKA, the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia (PSIA) group or a postoperative local infiltration analgesia (PLIA) group and administered different pain management protocols during surgery. Clinical evaluation will be conducted at baseline, before surgery, and at 6, 12, 24, 48, and 72 hours postoperatively, as well as during follow-up visits at 3 weeks, 6 weeks and 6 months postoperatively. All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6, 12, 24, 48, 72, and 96 weeks later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA.
Detailed description
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). This study aims to recruit 110 patients across a single centre over 1 year. Eligible patients will be included in this study after signing the informed consent form. Before TKA, the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia (PSIA) group or a postoperative local infiltration analgesia (PLIA) group and administered different pain management protocols during surgery. Clinical evaluation will be conducted at baseline, before surgery, and at 6, 12, 24, 48, and 72 hours postoperatively, as well as during follow-up visits at 3 weeks, 6 weeks and 6 months postoperatively. The primary outcomes are the amount of morphine consumed within 0-24 hours postsurgery and the visual analogue scale (VAS) score postsurgery. Secondary outcomes include the time to first rescue analgesia, total morphine consumption during hospitalization, postoperative joint function (measured by the Hospital for Special Surgery [HSS] score and knee joint range of motion [ROM]), intraoperative bleeding and serological indicators. All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6h, 12h, 24h, 48h, 72h, 3 weeks, 6 weeks and 6 months later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA. Statistical analyses utilizing regression models and survival analysis will be conducted to assess the relationships between the pain management method and postoperative pain and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial employs a random allocation method. A randomization table will be generated using SPSS 26.0 software. Treatment groups will be selected based on patients' random numbers, ensuring that this clinical institution stratifies the subjects into a PSIA group and a PLIA group at a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| preemptive stepwise infiltration anaesthesia(PSIA) group | Experimental | Procedure: preemptive stepwise infiltration anaesthesia(PSIA)Drugs：A cocktail of anaesthetics (30 mg of ropivacaine, 0.3 mg of adrenaline) will be prepared, diluted with normal saline to 120 mL, and divided into two equal parts(Cocktail A[CA] and Cocktail B[CB]), with CB containing 8 mg of added betamethasone (each 1 ml of the compound contains 5 mg betamethasone dipropionate [calculated as betamethasone] and 2 mg of betamethasone sodium phosphate [calculated as betamethasone]). |
| postoperative local infiltration analgesia(PLIA) group | Active comparator | Procedure: postoperative local infiltration analgesia(PLIA)Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of primary unilateral knee osteoarthritis (KOA), confirmed by imaging as KOA (Kellgren-Lawrence score ≥2). The patient was scheduled for initial unilateral total knee arthroplasty (TKA) at our hospital.
- Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the evaluation criteria.
- Participants aged 18 years or older, both male and female.
- Ability to provide informed consent and sign a written informed consent form.
- The ability to comprehend the research requirements and willingness to cooperate with the study instructions.
Key exclusion criteria (9 listed)
- Previous knee surgery on the operative knee or a history of infection in the operative knee.
- Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis).
- Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30° and the use of unconventional arthroplasty components due to complex joint pathology [e.g., restrictive prostheses]).
- Allergy to the investigational drug.
- The presence of neuromuscular dysfunction on the operative side.
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 |
|---|---|---|
| preemptive stepwise infiltration anaesthesia(PSIA)For PSIA patients, the anaesthetic is administered in stages. Initially, CA is injected at the incision site before the medial parapatellar incision. Following skin incision, more CA is injected into the subcutaneous tissue. After exposing the fascial layer and joint capsule, CA is used around the patellar tendon, and then CB is injected into the joint capsule and surrounding muscles. Additional CB is applied to the synovium and soft tissues after the joint cavity is opened, and more is used in the posterior joint capsule after bone resection. | Procedure or surgery | preemptive stepwise infiltration anaesthesia(PSIA) group |
| postoperative local infiltration analgesia(PLIA)Before standardized TKA and implantation of the prosthesis, 30-40 mL of CB will be used to infiltrate the synovium and whole joint capsule. Subsequently, the joint cavity, subcutaneous tissue, and skin will be closed layer by layer using routine procedures. After the skin is closed, 30-40 mL of CA will be injected into the skin and subcutaneous tissue. | Procedure or surgery | postoperative local infiltration analgesia(PLIA) group |
Primary outcome
Postoperative morphine consumption within the first 24 hours
Time frame: the first 24 hours after TKA
Postoperative morphine consumption within the first 24 hours includes both routine analgesia and rescue analgesia, which will be converted to oral morphine equivalents (OMEs)
. Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA
VAS scores are the most commonly used indicator for assessing the intensity of patient pain (15). The scale ranges from "0" to "10", where "0" indicates no pain and "10" represents the most severe pain that is unbearable. Patients will rate their pain based on subjective perceptions. In this trial, VAS scores will be recorded once before TKA. The VAS scores will be assessed separately for the resting and flexion states. If the patient's hospitalization period is shorter than 72 hours, the VAS score at discharge will be recorded instead of that at 72 hours. Studies have shown that some patients still experience joint pain six months after TKA. The VAS scores of patients at 6 months after TKA will be evaluated. A VAS score of 4 or above is defined as "chronic persistent pain after TKA." The results will be used to evaluate whether PSIA can reduce pain after TKA.
15 secondary outcomes
Postoperative time to first rescue analgesia
Time frame: up to 3 days
Total morphine consumption during hospitalization
Time frame: through study completion, an average of 6 months
The Hospital for Special Surgery Knee Score (HSS)
Time frame: 3 weeks, 6 weeks and 6 months postoperatively
Range of motion (ROM)
Time frame: 3 weeks, 6 weeks and 6 months postoperatively
Direct intraoperative bleeding
Time frame: 24 hours postoperatively
Indirect intraoperative bleeding
Time frame: 24 hours postoperatively
Complete blood count
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
C-reactive protein (CRP)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Erythrocyte sedimentation rate (ESR)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Interleukin-6 (IL-6)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Total bilirubin (TB)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Derect bilirubin (DB)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Aspartate aminotransferase (AST)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Alanine aminotransferase (ALT)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Creatinine (Cr)
Time frame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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.
Wenming Zhang, MD study director
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preemptive stepwise infiltration anaesthesia(PSIA) and postoperative local infiltration analgesia(PLIA) in people with Total Knee Arthroplasty and Pain Management, run by First Affiliated Hospital of Fujian Medical University 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 6 inclusion and 9 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 17 Oct 2024. 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 Xinyu Fang, MD (18084768503 Ext. 86, 9738006@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption within the first 24 hours (time frame: the first 24 hours after TKA). The study lists 2 primary outcomes in all. 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 17 Oct 2024.