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

NCT06458400 | Completed Phase 4

• 1 other identifier: TGRD-ANAL-PILOT-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

Analgesia; Biased μ-opioid receptor agonists

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• total pain relief (TOTPAR) scores

  10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose

• the percentage of patients receiving rescue analgesia

  from 0-24 hours after the first loading dose

• 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.

Study Arms (3)

tegileridine

EXPERIMENTAL

The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min

Drug: Tegileridine

oliceridine

EXPERIMENTAL

The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min

Drug: Oliceridine

morphine

ACTIVE COMPARATOR

The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min

Drug: Morphine

Interventions

Tegileridine DRUG

single dose+PCA dose

tegileridine

Oliceridine DRUG

single dose+PCA dose

oliceridine

Morphine DRUG

single dose+PCA dose

morphine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
• years old ≤ age ≤70 years old, regardless of gender;
• 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.

You may not qualify if:

• 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;
• Pregnant or lactating female subjects;
• Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Sponsors & Collaborators

• Yuwei Qiu: lead

Study Sites (1)

241 Huaihai West Road, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician, Associate director of anesthesiology, Associate professor

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 13, 2024
• Study Start: July 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 6, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)