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Compares treatment options for Total Knee Anthroplasty
Official title Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT07509866
What this study is testing
What is Liposomal bupivacaine (LB)?
Liposomal bupivacaine (LB) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for total knee anthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Effective postoperative pain management remains a cornerstone of enhanced recovery protocols following total knee arthroplasty (TKA). Inadequate analgesia not only compromises patient satisfaction but also impedes early mobilization and rehabilitation, thereby increasing the risk of perioperative complications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients scheduled for elective primary unilateral total knee arthroplasty
- Age ≥ 18 years and ≤ 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) ≥ 18 kg/m² and ≤ 35 kg/m²
- Ability to understand and provide written informed consent
You likely can't join if
- Known allergy or contraindication to local anesthetics (bupivacaine, ropivacaine), dexamethasone, dexmedetomidine, or opioids
- Infection at the injection site
- Coagulopathy or current use of anticoagulants
- Severe cardiovascular disease (New York Heart Association [NYHA] functional class III or IV, or recent myocardial infarction within 6 months)
- Severe hepatic impairment (Child-Pugh class C) or renal impairment (estimated glomerular filtration rate [eGFR] \< 30 mL/min/1.73 m²)
- Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg despite medical therapy)
See the full eligibility criteria
- Patients scheduled for elective primary unilateral total knee arthroplasty
- Age ≥ 18 years and ≤ 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) ≥ 18 kg/m² and ≤ 35 kg/m²
- Ability to understand and provide written informed consent
- Known allergy or contraindication to local anesthetics (bupivacaine, ropivacaine), dexamethasone, dexmedetomidine, or opioids
- Infection at the injection site
- Coagulopathy or current use of anticoagulants
- Severe cardiovascular disease (New York Heart Association [NYHA] functional class III or IV, or recent myocardial infarction within 6 months)
- Severe hepatic impairment (Child-Pugh class C) or renal impairment (estimated glomerular filtration rate [eGFR] \< 30 mL/min/1.73 m²)
- Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg despite medical therapy)
- Uncontrolled diabetes mellitus (HbA1c \> 8.5%)
- Bilateral TKA or revision TKA
- Chronic opioid use (daily opioid consumption for \> 3 months prior to surgery)
- Participation in another treatment clinical trial within 30 days prior to enrollment
- Inability to communicate with study personnel or complete pain assessments (e.g., language barrier, cognitive impairment)
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.