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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: liposomal bupivacaine groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption within 72 hours after surgery

Time frame
72 hours after surgery

Secondary outcomes

1

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;
2

Area under the curve of VAS pain scores

Time frame
within 72 hours and 1 week after surgery
3

Quality of recovery

assessed using the QoR-15 scale

Time frame
within 1 week after surgery
4

Sleep quality within 1 week after surgery

assessed using the Insomnia Severity Index (ISI)

Time frame
within 1 week after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: