To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment o… (NCT06458400) | Clinical Trial Compass
CompletedPhase 4
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
China75 participantsStarted 2024-07-03
Plain-language summary
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
. 18 years old ≤ age ≤70 years old, regardless of gender;
. 18 kg/m2≤BMI≤30 kg/m2;
. American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
. Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
. Before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
Timeframe: during the first 24 hours after starting a loading dose of test drug infusion
. Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation \< 90%, or a history of acute or severe bronchial asthma;
. Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
. Known or suspected gastric bowel obstruction, including paralytic ileus patients;
. Patients with allergy to opioids or any component of the trial drug;
. Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
. With late-stage malignant tumors or with extensive metastasis of malignant tumor patients;
. Subjects with other somatic pain that may affect postoperative pain assessment;
. A history of drug, drug, and/or alcohol abuse within 1 year before randomization;