Comparing two methods for pain control after lung surgery

Effects of Liposomal Bupivacaine Combined With Bupivacaine and Dexamethasone for Rhomboid Intercostal Block on Postoperative Pain Following Video-Assisted Thoracoscopic Surgery: A Non-inferiority, Double-blind, Randomized Trial.

This study is testing whether a new way of delivering pain relief after lung surgery works better than the standard method for patients recovering from the procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Affiliated Hospital of Jiaxing University (Academic / other)
• Locations: 1 site (Jiaxing, Zhejiang)
• Trial ID: NCT06392191 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain management in patients undergoing thoracoscopic lung resection. It compares the use of bupivacaine liposomes with standard bupivacaine hydrochloride combined with dexamethasone to determine which method provides better pain relief and longer-lasting analgesia. The study will enroll 90 patients aged 18-80 years who are scheduled for elective surgery, and it will assess the quality of postoperative recovery in both groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 scheduled for elective thoracoscopic lung resection surgery with ASA physical status I-III.

Not a fit: Patients with severe comorbidities, such as unstable coronary artery disease or significant renal or liver dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing thoracoscopic lung surgery.

How similar studies have performed: Other studies have shown promising results with liposomal formulations for pain management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

ASA physical status I-III, aged between 18 and 80 years, scheduled for elective thoracoscopic lung resection surgery under general anesthesia with endotracheal intubation (including wedge resection, segmentectomy, or lobectomy) with one or three incisions, expected duration of surgery less than 4 hours, and body mass index (BMI) between 18 and 30 kg/m².

Exclusion Criteria:

1. trauma or emergency patients;
2. patients classified as New York Heart Association (NYHA) functional class 3-4;
3. unstable coronary artery disease patients;
4. patients with renal system diseases (estimated glomerular filtration rate \<30 mL/min/1.73 m²);
5. patients with liver system diseases (alanine aminotransferase or aspartate aminotransferase levels exceeding twice the normal value);
6. patients with coagulation disorders, or those who have not discontinued warfarin or novel anticoagulants (such as rivaroxaban, dabigatran) prior to surgery;
7. individuals with a history of alcohol abuse or substance dependence within the past two months;
8. patients with uncontrolled anxiety, schizophrenia, or other psychiatric disorders;
9. pregnant or planning to become pregnant women;
10. individuals with a history of allergy to local anesthetics or investigational drugs. Additionally, patients who refuse to sign the informed consent form will also be excluded;
11. chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome);
12. chronic opioid use (longer than 3 months or daily morphine equivalents more than 5 mg/day for 1 month).

Where this trial is running

Jiaxing, Zhejiang

• The First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: QINGhe ZHOU, professor — deputy chair of board
• Study coordinator: Qinghe ZHOU, professor

Conditions Thoracic Surgery; Rhombic intercostal nerve block; thoracoscopy; Bupivacaine liposomes