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Not yet recruiting NCT07641647

The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study

Phase IV Interventional Lung Transplantation Pain Management 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: LB/BH intercostal nerve block, BH intercostal nerve block.
Who it may be relevant to
Registry conditions: Lung Transplantation, Pain Management, Liposomal Bupivacaine. Basic parameters: No limits · 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 →

Overview

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in adult patients undergoing lung transplantation. The main questions it aims to answer are: Does liposomal bupivacaine reduce postoperative opioid consumption after lung transplantation? Does liposomal bupivacaine relieve postoperative pain without increasing adverse events? Researchers will compare patients receiving liposomal bupivacaine combined with bupivacaine hydrochloride with patients receiving bupivacaine hydrochloride alone to see whether liposomal bupivacaine provides better postoperative analgesia and reduces opioid requirements after lung transplantation. Participants will: Receive lung transplantation under standard perioperative care. Receive intercostal nerve block with either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone. Be assessed for postoperative opioid consumption, pain scores, recovery-related outcomes, and adverse events after surgery.

Interventions

  • Drug LB/BH intercostal nerve block
    Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
  • Drug BH intercostal nerve block
    Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.

Primary outcome measures

  • Opioid consumption within 72 hours after surgery [Time frame: 72 hours after surgery]
Secondary outcome measures (12)
  • VAS pain scores [Time frame: at 24 hours, 48 hours, 72 hours, and 1 week after surgery;]
  • Area under the curve of VAS pain scores [Time frame: within 72 hours and 1 week after surgery]
  • Quality of recovery [Time frame: within 1 week after surgery]
  • Sleep quality within 1 week after surgery [Time frame: within 1 week after surgery]
  • Anxiety and depression [Time frame: within 1 week after surgery]
  • Length of ICU stay [Time frame: within 90 days]
  • total hospital stay [Time frame: within 90 days]
  • Incidence of chronic pain [Time frame: at 3 months after surgery]
  • sleep quality [Time frame: at 3 months after surgery]
  • anxiety and depression [Time frame: at 3 months after surgery]
  • quality of recovery [Time frame: at 3 months after surgery]
  • Incidence of adverse events [Time frame: within 90 days]

Eligibility criteria

Inclusion criteria

  • Patients with end-stage lung disease undergoing bilateral lung transplantation; Age >18 years; Expected discontinuation of mechanical ventilation within 48 hours after surgery; The patient or legally authorized representative signs the informed consent form and agrees to participate in the study and follow-up.

Exclusion criteria

  • Body mass index ≤18 kg/m² or ≥35 kg/m²; Allergy or contraindication to local anesthetics; Preoperative tracheal intubation or requirement for extracorporeal life support; Expected use of other types of nerve block; Active systemic infection or infection at the planned block site; Severe hepatic insufficiency; Severe renal impairment; Chronic pain, neuropathic pain, long-term use of analgesics, or use of other psychotropic medications; Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric disorders; Severe coagulation dysfunction; Concomitant surgery during the same operative session; Pregnant or breastfeeding women.

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
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou

Identifiers

NCT: NCT07641647 · 2026-0791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗