Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSanming First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
History of local anesthetic allergy.
Chronic opioid users.
Contraindications for nerve block, including infection at the puncture site and coagulation disorders;
Language communication impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine Hydrochloride
DrugSingle-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.
Bupivacaine liposome
DrugSingle-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Liposome bupivacaine groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Quality of Recovery at 24 hours
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.
Time frame
24 hours after surgerySecondary outcomes
1
Postoperative Quality of Recovery at 48 hours
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.
Time frame
48 hours after surgery2
Area Under the Curve (AUC) of Pain Scores in the First 48 Hours
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.
Time frame
From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points)3
Cumulative Morphine Consumption in the First 48 Hours
Total cumulative morphine consumption (in mg) recorded from the patient-controlled analgesia (PCA) device during the first 48 hours after surgery.
Time frame
First 48 hours after surgery4
Time to First PCA Demand
Time interval from arrival in the post-anesthesia care unit (PACU) to the first demand dose of patient-controlled intravenous analgesia (PCIA).
Time frame
Up to 48 hoursOther outcomes
1
Incidence of Adverse Events
All adverse events occurring within the first 48 hours after surgery are recorded using a standardized case report form (CRF). Adverse events are categorized by system organ class, severity, and relationship to the study intervention.
Time frame
First 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov