Pulmonary Nodule, Liposomal Bupivacaine
Conditions
Keywords
Liposomal bupivacaine, Intercostal nerve block
Brief summary
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak pain period after surgery. Liposomal bupivacaine is a long-acting formulation designed to provide extended analgesia up to 72 hours. This study aims to evaluate the effect of preoperative ICNB with liposomal bupivacaine compared with conventional bupivacaine hydrochloride on postoperative quality of recovery in patients undergoing VATS partial pneumonectomy. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. We hypothesize that liposomal bupivacaine ICNB results in superior recovery quality compared with conventional bupivacaine, with reduced postoperative pain and opioid consumption.
Interventions
DRUGBupivacaine Hydrochloride
Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.
Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.
Sponsors
Sanming First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for thoracic surgery under general anesthesia via thoracoscopic approach; * Age 18-65 years; * Classified as Grade I-II by the American Society of Anesthesiologists (ASA).
Exclusion criteria
* History of local anesthetic allergy. * Chronic opioid users. * Contraindications for nerve block, including infection at the puncture site and coagulation disorders; * Language communication impairment. * Other conditions unsuitable for inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Quality of Recovery at 24 hours | 24 hours after surgery | Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Quality of Recovery at 48 hours | 48 hours after surgery | Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery. |
| Area Under the Curve (AUC) of Pain Scores in the First 48 Hours | From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points) | Pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at 0, 1, 3, 6, 12, 24, 36, and 48 hours after arrival in the post-anesthesia care unit (PACU), separately for pain at rest and pain during coughing (movement). AUC is calculated using the trapezoidal method. |
| Cumulative Morphine Consumption in the First 48 Hours | First 48 hours after surgery | Total cumulative morphine consumption (in mg) recorded from the patient-controlled analgesia (PCA) device during the first 48 hours after surgery. |
| Time to First PCA Demand | Up to 48 hours | Time interval from arrival in the post-anesthesia care unit (PACU) to the first demand dose of patient-controlled intravenous analgesia (PCIA). |
| Patient Satisfaction | 48 hours after surgery | Patient satisfaction with postoperative analgesia assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied. |
| Duration of PACU Stay | From PACU arrival to Aldrete score ≥9, up to 1 hour | Time interval from arrival in the post-anesthesia care unit (PACU) until the Aldrete score reaches ≥9. |
| Emergence time | Up to 1 hour | Time interval from discontinuation of anesthetic agents until the patient shows a purposeful response to verbal command. |
| Intraoperative Remifentanil Consumption | Intraoperative period (from anesthesia maintenance initiation to end of surgery) | Total intraoperative remifentanil consumption (in μg) from the start of anesthesia maintenance until the end of surgery. |
Contacts
CONTACTHuifen Lin, MD
PRINCIPAL_INVESTIGATORHuifen Lin, MD
No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province
Outcome results
None listed