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

Phase 4Not Yet RecruitingNCT07641647

Second Affiliated Hospital, School of Medicine, Zhejiang University88 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Lung Transplantation Pain Management Liposomal Bupivacaine

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Opioid consumption within 72 hours after surgery

Time frame: 72 hours after surgery

Secondary Outcomes

VAS pain scores

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

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

assessed using the QoR-15 scale

Time frame: within 1 week after surgery

Sleep quality within 1 week after surgery

assessed using the Insomnia Severity Index (ISI)

Time frame: within 1 week after surgery

Anxiety and depression

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.

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

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

Time frame: at 3 months after surgery

sleep quality

Sleep quality was assessed using the Insomnia Severity Index.

Time frame: at 3 months after surgery

anxiety and depression

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

Time frame: at 3 months after surgery

quality of recovery

ssessed using the QoR-15 scale

Time frame: at 3 months after surgery

Incidence of adverse events

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

Time frame: within 90 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts