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NCT Number: NCT07641647

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

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.

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Key information

Conditions

Lung Transplantation Agnosia Liposomal Bupivacaine Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location contact

Min Yan

CONTACT

[email protected]

13757118632

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

LB/BH intercostal nerve block

Drug

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

BH intercostal nerve block

Drug

Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.

Primary outcomes

  1. Opioid consumption within 72 hours after surgery

    Time frame: 72 hours after surgery

Secondary outcomes

  1. VAS pain scores

    Time frame: at 24 hours, 48 hours, 72 hours, and 1 week after surgery;

    ranging from 0 to 100 mm, with 0 indicating no pain and 100 indicating the worst imaginable pain.

  2. Area under the curve of VAS pain scores

    Time frame: within 72 hours and 1 week after surgery

  3. Quality of recovery

    Time frame: within 1 week after surgery

    assessed using the QoR-15 scale

  4. Sleep quality within 1 week after surgery

    Time frame: within 1 week after surgery

    assessed using the Insomnia Severity Index (ISI)

  5. Anxiety and depression

    Time frame: within 1 week after surgery

    Anxiety and depression symptoms were assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD), respectively, with HAMA ranging from 0 to 56 and HAMD ranging from 0 to 52.

  6. Length of ICU stay

    Time frame: within 90 days

  7. total hospital stay

    Time frame: within 90 days

  8. Incidence of chronic pain

    Time frame: at 3 months after surgery

    Chronic pain was defined as the incidence of pain 3 months post-surgery, assessed using the VAS score.

  9. sleep quality

    Time frame: at 3 months after surgery

    Sleep quality was assessed using the Insomnia Severity Index.

  10. anxiety and depression

    Time frame: at 3 months after surgery

    assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);

  11. quality of recovery

    Time frame: at 3 months after surgery

    ssessed using the QoR-15 scale

  12. Incidence of adverse events

    Time frame: within 90 days

    including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.

Study contacts

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

Min Yan

CONTACT

[email protected]

13757118632

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 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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