Clinical trial NCT06458400: To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
Official title: To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Keywords: Analgesia
Biased μ-opioid receptor agonists
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
2. 18 years old ≤ age ≤70 years old, regardless of gender;
3. 18 kg/m2≤BMI≤30 kg/m2;
4. American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
5. Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
6. 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:

1. 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;
2. 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);
3. Known or suspected gastric bowel obstruction, including paralytic ileus patients;
4. Patients with allergy to opioids or any component of the trial drug;
5. Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
6. With late-stage malignant tumors or with extensive metastasis of malignant tumor patients;
7. Subjects with other somatic pain that may affect postoperative pain assessment;
8. A history of drug, drug, and/or alcohol abuse within 1 year before randomization;
9. Pregnant or lactating female subjects;
10. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Resting-state pain and exercise-state pain intensity
timeFrame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
measure: Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion
timeFrame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
measure: total pain relief (TOTPAR) scores
timeFrame: 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
measure: the percentage of patients receiving rescue analgesia
timeFrame: from 0-24 hours after the first loading dose
measure: length of bed stay
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
measure: Length of hospital stay
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
measure: incidence of Postoperative nausea and vomiting
timeFrame: the first 24 hours after surgery
measure: incidence rate of respiratory depression
timeFrame: the first 24 hours after surgery
measure: analgesia satisfaction
timeFrame: the first 24 hours after surgery
measure: pressing times of postoperative analgesic pump
timeFrame: the first 24 hours after surgery
measure: total doses of postoperative analgesic pump
timeFrame: the first 24 hours after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 241 Huaihai West Road, Xuhui District, Shanghai
state: Shanghai
Study officials:
References: