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Tests treatment safety and results for Video-assisted Thoracoscopic Surgery (VATS)
Official title The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery
ClinicalTrials.gov ID: NCT07432711
What this study is testing
What is Bupivacaine hydrochloride?
Bupivacaine hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for video-assisted thoracoscopic surgery (vats).
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
- Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy. It is reported that the incidence of acute pain following VATS exceeds 80%.
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 64
You may be able to join if
- Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;
- Ages 18 to 64 years old；
- American Society of Anesthesiologists (ASA) physical status of I-III；
- Glasgow Coma Scale (GCS) score of 15；
- Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
You likely can't join if
- History of chronic pain syndrome of any cause.
- Patients with heart conduction block (sinus block or atrioventricular block).
- Patients with unstable coronary artery disease.
- Patients with gastric ulcer or gastric bleeding.
- Patients with diabetes and are being treated with insulin.
- people with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who...
See the full eligibility criteria
- Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;
- Ages 18 to 64 years old；
- American Society of Anesthesiologists (ASA) physical status of I-III；
- Glasgow Coma Scale (GCS) score of 15；
- Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
- History of chronic pain syndrome of any cause.
- Patients with heart conduction block (sinus block or atrioventricular block).
- Patients with unstable coronary artery disease.
- Patients with gastric ulcer or gastric bleeding.
- Patients with diabetes and are being treated with insulin.
- people with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not...
- Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
- Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
- Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
- Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within...
- Pregnancy or breastfeeding.
- Extreme body mass index (BMI) (\ 35).
- Participation in another treatment trial that interferes with the intervention or outcome of this trial.
- Patients with a history of allergy to local anaesthetics or one of the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.