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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Tegileridine; Drug: Oliceridine; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • 241 Huaihai West Road, Xuhui District, Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tegileridine; The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min	Drug: Tegileridine; single dose+PCA dose
Experimental: oliceridine; The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min	Drug: Oliceridine; single dose+PCA dose
Active Comparator: morphine; The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min	Drug: Morphine; single dose+PCA dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-weighted sum of differences of resting pain score within 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	during the first 24 hours after starting a loading dose of test drug infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuwei Qiu

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 6, 2024

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Analgesia; Biased μ-opioid receptor agonists
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: TGRD-ANAL-PILOT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share when necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No