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OpenTrials
Completed

NCT Number: NCT06458400

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

241 Huaihai West Road, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Tegileridine

Drug

single dose+PCA dose

Oliceridine

Drug

single dose+PCA dose

Morphine

Drug

single dose+PCA dose

Primary outcomes

  1. Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion

    Time frame: 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 outcomes

  1. Resting-state pain and exercise-state pain intensity

    Time frame: 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

  2. Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion

    Time frame: 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

  3. total pain relief (TOTPAR) scores

    Time frame: 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

  4. the percentage of patients receiving rescue analgesia

    Time frame: from 0-24 hours after the first loading dose

    the percentage of patients receiving rescue analgesia

  5. length of bed stay

    Time frame: 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

  6. Length of hospital stay

    Time frame: 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

  7. incidence of Postoperative nausea and vomiting

    Time frame: the first 24 hours after surgery

    incidence rate of PONV

  8. incidence rate of respiratory depression

    Time frame: the first 24 hours after surgery

    respiratory depression is defined as respiratory rate < 8 and/or SpO2<90%

  9. analgesia satisfaction

    Time frame: the first 24 hours after surgery

    satisfaction evaluation using 0-100 scale

  10. pressing times of postoperative analgesic pump

    Time frame: the first 24 hours after surgery

  11. total doses of postoperative analgesic pump

    Time frame: the first 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Yuwei Qiu

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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