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NCT Number: NCT07512635

Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy

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.

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Key information

Conditions

Pulmonary Nodule Liposomal Bupivacaine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.

Other names: Marcaine, Sensorcaine

Bupivacaine liposome

Drug

Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.

Other names: Exparel, liposomal bupivacaine

Primary outcomes

  1. Postoperative Quality of Recovery at 24 hours

    Time frame: 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 outcomes

  1. Postoperative Quality of Recovery at 48 hours

    Time frame: 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.

  2. Area Under the Curve (AUC) of Pain Scores in the First 48 Hours

    Time frame: 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.

  3. Cumulative Morphine Consumption in the First 48 Hours

    Time frame: 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.

  4. Time to First PCA Demand

    Time frame: 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).

  5. Patient Satisfaction

    Time frame: 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.

  6. Duration of PACU Stay

    Time frame: 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.

  7. Emergence time

    Time frame: Up to 1 hour

    Time interval from discontinuation of anesthetic agents until the patient shows a purposeful response to verbal command.

  8. Intraoperative Remifentanil Consumption

    Time frame: 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.

Other outcomes

  1. Incidence of Adverse Events

    Time frame: First 48 hours after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huifen Lin, MD

CONTACT

[email protected]

（0598）8803263

Sponsors and collaborators

Lead sponsor

Sanming First Hospital

Other

Registry information

Official study title

Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Postoperative Quality of Recovery in Patients Undergoing Video-assisted Thoracoscopic Partial Pneumonectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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