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Recruiting NCT07512635

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

Phase IV Interventional Pulmonary Nodule Liposomal Bupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine Hydrochloride, Bupivacaine liposome.
Who it may be relevant to
Registry conditions: Pulmonary Nodule, Liposomal Bupivacaine. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug Bupivacaine Hydrochloride
    Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.
  • Drug Bupivacaine liposome
    Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.

Primary outcome measures

  • Postoperative Quality of Recovery at 24 hours [Time frame: 24 hours after surgery]
Secondary outcome measures (8)
  • Postoperative Quality of Recovery at 48 hours [Time frame: 48 hours after surgery]
  • 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)]
  • Cumulative Morphine Consumption in the First 48 Hours [Time frame: First 48 hours after surgery]
  • Time to First PCA Demand [Time frame: Up to 48 hours]
  • Patient Satisfaction [Time frame: 48 hours after surgery]
  • Duration of PACU Stay [Time frame: From PACU arrival to Aldrete score ≥9, up to 1 hour]
  • Emergence time [Time frame: Up to 1 hour]
  • Intraoperative Remifentanil Consumption [Time frame: Intraoperative period (from anesthesia maintenance initiation to end of surgery)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • SanMing First Hospital — Sanming

Identifiers

NCT: NCT07512635 · Ming-Yi-Yuan-Ethics-2024-54/02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗