New painkiller could ease recovery after lung surgery
NCT ID NCT06529432
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a long-acting painkiller (bupivacaine liposome) injected near the spine to control pain after lung surgery. About 96 adults having a specific type of lung surgery will receive either the new drug or a standard painkiller. The goal is to see if the new drug provides better pain relief with fewer side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects who are willing to strictly follow the clinical trial protocol to complete this study and voluntarily sign informed consent; 2. Elective surgical subjects undergoing lobectomy by single-aperture thoracoscope under general anesthesia; 3. age ≥18 years old , Male or female; 4. 18 kg/m2≤BMI≤30 kg/m2; 5. ASA Physical Status Classification I-II; 6. Female subjects of childbearing potential must agree to use contraception and refrain from egg donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug. Serum or urine pregnancy tests must be negative before dosing and during the trial, and they must not be lactating. Male subjects with partners of childbearing potential must agree to use contraception and refrain from sperm donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug. Exclusion Criteria: Participants with any of the following criteria were excluded from the study: 1. Pre-existing and combined diseases: (1) Subjects with a history of myocardial infarction or unstable angina pectoris, or a history of severe arrhythmias such as atrioventricular block of degree II and above, or NYHA grade II and above in the 6 months before randomization; (2) Subjects with a history of ischemic stroke or transient ischemic attack (TIA); (3) Subjects with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; (4) Subjects with sensory disorders such as hyperalgesia; (5) Subjects with other physical pain witch may affect the evaluation of postoperative pain; (6) Subjects with airway or spinal anatomic factors caused by obstruction of ventilation, bronchiectasis, severe intraoperative thoracic adhesion, etc. 2\. Laboratory and other tests: 1. Abnormal laboratory results during screening. •Fasting blood glucose (FPG) ≥10.0mmol/L. •Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) ≥1.5×ULN. * Abnormal renal function: serum creatinine (Cr) ≥1.5×ULN, or dialysis subjects. * Abnormal coagulation function: PT\> upper normal value +3s and/or APTT \> upper normal value +10s. * Platelet (PLT) \<80×109/L. * Hemoglobin concentration (Hb) \< 70g/L. 2. Screening period heart rate \< 50 beats/min or heart rate \> 100 beats/min; 12-lead ECG QTc interval prolonged: male ≥450ms, female ≥470ms. 3. Subjects with refractory hypertension or a history of refractory hypertension before randomization. 3\. Combined drugs: 1. Subjects who allergic to or contraindicated with bupivacaine, other amide local anesthetics, and other drugs that may be used during the trial (e.g., propofol, remazolam, opioids, etc.). 2. Subjects who used any of the following drugs within 5 drug half-lives prior before randomization (drug half-lives are based on actual drug instructions, or at least 48 hours of elution if half-lives are unknown): * Class III antiarrhythmic drugs such as amiodarone. * Drugs that affect liver metabolism: strong CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine; CYP1A2 substrates: such as theophylline, imipramine; Strong CYP3A4 inhibitors such as voriconazole, ketoconazole, Ritonavir; CYP3A4 substrates such as darunavir, Indinavir, saquinavir; Strong CYP3A4 inducers such as rifampin. * Intravenous or oral corticosteroids. * Sedative drugs: benzodiazepines (such as diazepam, flurazepam, oxazepam, cloazepine, triazolam, alprazolam, esazolam, midazolam, etc.), barbiturates, carbamazepine, phenytoin, magnesium sulfate, chloral hydrate, etc.. * Pain relief and other drugs: Nonsteroidal anti-inflammatory drugs (aspirin is permitted for the prevention of cardiovascular events, provided it is used steadily for at least 30 days prior to randomization, Daily dose ≤100mg/ day), opioid agonists/antagonists, central alpha-adrenergic agonists (e.g. Clonidine, dexmedetomidine), anticonvulsants (e.g. Carbamazepine, pregabalin, gabapentin), antidepressants (e.g. Tricyclic, selective 5-HT reuptake inhibitors). 4\. Others: (1) Subjects had a history of substance abuse, drug use, and/or alcohol abuse within the 1 year prior to randomization, with alcohol abuse defined as drinking an average of more than 2 units of alcohol per day (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150 ml wine); Or consume alcoholic food or drink within 24 hours before receiving the study drug. (2) Subjects consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, grapefruit juice, caffeinated beverages (averaging more than 8 cups per day, 200 mL per cup) in the 14 days prior to randomization. (3) Subjects who have participated in other clinical trials as subjects, and/or previously received investigational drug or device in this clinical trial within the 3 months prior to randomization. (4) Subjects who have any other factors deemed unsuitable for participation in this trial by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Local analgesia via nerve block are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Zhongshan Hospital Affiliated to Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China