Pain Management
Conditions
Keywords
Postoperative pain, Thoracoscopic surgery, Intrapleural analgesia
Brief summary
Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited. This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels. This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.
Detailed description
Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited. This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels. This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.
Interventions
Bupivacaine 0.125% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.
DRUGBupivacaine 0.25%
Bupivacaine 0.25% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.
DRUGNormal Saline
Normal saline is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery.
OTHERMultimodal Analgesia
All participants receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated, in addition to the assigned intrapleural intervention.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for elective video-assisted thoracoscopic surgery 2. Age≥18 years 3. American Society of Anesthesiologists (ASA) physical status classification I-III
Exclusion criteria
1. Pregnancy or breastfeeding 2. History of chronic pain 3. History of alcohol or opioid dependence 4. Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities 5. Coexisting central nervous system disorders 6. Hepatic or renal dysfunction 7. Known hypersensitivity to local anesthetics or opioids 8. Local infection at or near the planned site of regional anesthesia, or systemic infection 9. Language impairment or difficulty in communication 10. Refusal to participate in the study or refusal to use patient-controlled analgesia 11. Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Pain Intensity During Coughing | 1, 2, 6, 12, 24, 36, and 48 hours postoperatively | Pain intensity during coughing will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated measurements to reflect overall pain burden during the first 48 hours after surgery. Pain assessments will be performed by trained study evaluators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Resting Pain Intensity | 1, 2, 6, 12, 24, 36, and 48 hours postoperatively | Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated assessments to evaluate cumulative resting pain during the first 48 hours after surgery. Assessments will be performed by trained study evaluators. |
| Postoperative Opioid Consumption | Up to 48 hours postoperatively | Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed. |
| Quality of Recovery | Baseline (preoperative), 24 hours, and 48 hours postoperatively | Postoperative recovery quality will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40), which evaluates multiple domains of postoperative recovery. |
Countries
China
Contacts
CONTACTLeo Li
Outcome results
None listed