Lung TransplantationPhase 4NCT07641647
The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study
A Phase 4 study testing LB/BH intercostal nerve block and BH intercostal nerve block in people with Lung Transplantation and Pain Management, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation, Pain Management, Liposomal Bupivacaine
- What is being tested?
- LB/BH intercostal nerve block and BH intercostal nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, 13757118632, zryanmin@zju.edu.cn
About this 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?
Read more
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.
- Conditions
- Lung Transplantation, Pain Management, Liposomal Bupivacaine
- Being tested
- LB/BH intercostal nerve block, BH intercostal nerve block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB/BH intercostal nerve blockDrug
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
BH intercostal nerve blockDrug
Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
| Study group | Role | What they receive |
|---|---|---|
| liposomal bupivacaine group | Experimental | Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery. Receives: Drug: LB/BH intercostal nerve block |
| control group | Active comparator | Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery. Receives: Drug: BH intercostal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption within 72 hours after surgery
Measured: 72 hours after surgery
Secondary outcomes (12)
VAS pain scores
ranging from 0 to 100 mm, with 0 indicating no pain and 100 indicating the worst imaginable pain.
Measured: at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
Area under the curve of VAS pain scores
Measured: within 72 hours and 1 week after surgery
Quality of recovery
assessed using the QoR-15 scale
Measured: within 1 week after surgery
Sleep quality within 1 week after surgery
assessed using the Insomnia Severity Index (ISI)
Measured: 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.
Measured: within 1 week after surgery
Length of ICU stay
Measured: within 90 days
total hospital stay
Measured: 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.
Measured: at 3 months after surgery
sleep quality
Sleep quality was assessed using the Insomnia Severity Index.
Measured: at 3 months after surgery
anxiety and depression
assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);
Measured: at 3 months after surgery
quality of recovery
ssessed using the QoR-15 scale
Measured: at 3 months after surgery
Incidence of adverse events
including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641647
- Sponsor's protocol ID
- 2026-0791
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07641647
- Acronym / sponsor ID
- 2026-0791
- Conditions
- Lung Transplantation, Pain Management, Liposomal Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposomal bupivacaine group | Experimental | Drug: LB/BH intercostal nerve blockPatients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery. |
| control group | Active comparator | Drug: BH intercostal nerve blockPatients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB/BH intercostal nerve blockPatients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation. | Drug | liposomal bupivacaine group |
| BH intercostal nerve blockPatients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation. | Drug | control group |
Primary outcome
Opioid consumption within 72 hours after surgery
Time frame: 72 hours after surgery
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LB/BH intercostal nerve block and BH intercostal nerve block in people with Lung Transplantation and Pain Management, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan (13757118632, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption within 72 hours after surgery (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.