Intrapleural Bupivacaine Analgesia for Postoperative Pain Management After Minimally Invasive Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

NCT07393386 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IDLJ-20251125
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

Postoperative pain; Thoracoscopic surgery; Intrapleural analgesia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Pain Intensity During Coughing

  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.

  1, 2, 6, 12, 24, 36, and 48 hours postoperatively

Secondary Outcomes (3)

• Area Under the Curve of Resting Pain Intensity

  1, 2, 6, 12, 24, 36, and 48 hours postoperatively

• Postoperative Opioid Consumption

  Up to 48 hours postoperatively

• Quality of Recovery

  Baseline (preoperative), 24 hours, and 48 hours postoperatively

Other Outcomes (5)

• Plasma Bupivacaine Concentration

  From pre-administration to 48 hours postoperatively

• Patient Satisfaction With Pain Management

  48 hours postoperatively

• Rescue Analgesic Consumption

  Up to 48 hours postoperatively

Study Arms (3)

0.25% Bupivacaine Intrapleural Analgesia

EXPERIMENTAL

Participants receive programmed intermittent intrapleural administration of 0.25% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.

Drug: Bupivacaine 0.25%; Other: Multimodal Analgesia

0.125% Bupivacaine Intrapleural Analgesia

EXPERIMENTAL

Participants receive programmed intermittent intrapleural administration of 0.125% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.

Drug: Bupivacaine 0.125%; Other: Multimodal Analgesia

Placebo Intrapleural Analgesia (Normal Saline)

PLACEBO COMPARATOR

Participants receive programmed intermittent intrapleural administration of normal saline via a chest drainage tube connected to a programmed infusion pump as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.

Drug: Normal Saline; Other: Multimodal Analgesia

Interventions

Bupivacaine 0.125% DRUG

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.

0.125% Bupivacaine Intrapleural Analgesia

Bupivacaine 0.25% DRUG

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.

0.25% Bupivacaine Intrapleural Analgesia

Normal Saline DRUG

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.

Placebo Intrapleural Analgesia (Normal Saline)

Multimodal Analgesia OTHER

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.

0.125% Bupivacaine Intrapleural Analgesia; 0.25% Bupivacaine Intrapleural Analgesia; Placebo Intrapleural Analgesia (Normal Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective video-assisted thoracoscopic surgery
• Age≥18 years
• American Society of Anesthesiologists (ASA) physical status classification I-III

You may not qualify if:

• Pregnancy or breastfeeding
• History of chronic pain
• History of alcohol or opioid dependence
• Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities
• Coexisting central nervous system disorders
• Hepatic or renal dysfunction
• Known hypersensitivity to local anesthetics or opioids
• Local infection at or near the planned site of regional anesthesia, or systemic infection
• Language impairment or difficulty in communication
• Refusal to participate in the study or refusal to use patient-controlled analgesia
• Concurrent participation in another clinical trial

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Leo Li

CONTACT

021-18621710790; 18621710790@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Supporting documentation will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
• Access Criteria: De-identified individual participant data that underlie the results reported in the primary publication, as well as the study protocol and statistical analysis plan, will be available to qualified researchers. Requests must be submitted to the principal investigator and will be reviewed on a case-by-case basis. Access will be granted for scientifically sound proposals and subject to approval by the study team and the execution of a data use agreement.

Locations

CN (1)