BridgeMD
Tests treatment safety and results for Pain, Postoperative
Official title Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06740214
What this study is testing
What is 0.5% standard bupivacaine only?
0.5% standard bupivacaine only is an investigational medicine, being studied as a potential treatment for pain, postoperative.
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
- Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia.
- Phase 3: a large, late-stage study
- 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
- ASA I-III
- Age 18-80 years old
- Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery
- Able to speak and understand Cantonese or Mandarin or English
- Able to provide informed oral and written consent
You likely can't join if
- Revision TKA
- Single-stage bilateral TKA
- Complex primary TKA requiring use of stem/augment/constrained liner
- Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring...
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- History of chronic pain other than chronic knee pain
See the full eligibility criteria
- ASA I-III
- Age 18-80 years old
- Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery
- Able to speak and understand Cantonese or Mandarin or English
- Able to provide informed oral and written consent
- Revision TKA
- Single-stage bilateral TKA
- Complex primary TKA requiring use of stem/augment/constrained liner
- Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- History of chronic pain other than chronic knee pain
- History of immunosuppression
- Chronic use of glucocorticoids
- Chronic opioid use (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- History of congestive heart failure (NYHA 2)
- Alcohol or drug abuse
- Impaired renal function (defined as effective glomerular filtration rate \< 30ml/min/1.73m2
- Impaired liver function (defined as plasma bilirubin over 34mol/L; international normalized ratio [INR] \>= 1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
- Coagulopathy (platelet count \ = 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of adductor canal blocks
- Pre-existing neurological or muscular disorders
- Psychiatric illness
- Impaired mental state
- Pregnancy
- Local infection
- On immunosuppressants
- High body mass index (BMI) (\>=40)
- Patient refusal for regional nerve blocks or to conduct clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong, Hong Kong
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 Hong Kong, Hong Kong, Hong Kong. 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.