To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Drug: Tegileridine; Drug: Oliceridine; Drug: Morphine

• Registration Number: NCT06458400
• Lead Sponsor: Yuwei Qiu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-26
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-13
• Study Start: 2024-07-03
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tegileridine	Tegileridine	The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min
oliceridine	Oliceridine	The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min
morphine	Morphine	The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min

Primary Outcome Measures

Name	Time	Method
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion	during the first 24 hours after starting a loading dose of test drug infusion	"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain

Secondary Outcome Measures

Name	Time	Method
total doses of postoperative analgesic pump	the first 24 hours after surgery
Resting-state pain and exercise-state pain intensity	Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose	Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion	Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose	"exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and
incidence rate of respiratory depression	the first 24 hours after surgery	respiratory depression is defined as respiratory rate \< 8 and/or SpO2\<90%
total pain relief (TOTPAR) scores	10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose	Time-weighted sum of resting and moving state pain relief scores
pressing times of postoperative analgesic pump	the first 24 hours after surgery
the percentage of patients receiving rescue analgesia	from 0-24 hours after the first loading dose	the percentage of patients receiving rescue analgesia
length of bed stay	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.	length out of bed
Length of hospital stay	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.	postoperative length of hospital stay
incidence of Postoperative nausea and vomiting	the first 24 hours after surgery	incidence rate of PONV
analgesia satisfaction	the first 24 hours after surgery	satisfaction evaluation using 0-100 scale

Trial Locations

Locations (1)

241 Huaihai West Road, Xuhui District, Shanghai; 🇨🇳 Shanghai, Shanghai, China