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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458400
• Other study ID #: TGRD-ANAL-PILOT-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 6, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?-?;

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 ? or above, or ischemic stroke in NYHA class ? 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.

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Drug:
• Tegileridine
single dose+PCA dose
• Oliceridine
single dose+PCA dose
• Morphine
single dose+PCA dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuwei Qiu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	the percentage of patients receiving rescue analgesia	the percentage of patients receiving rescue analgesia	from 0-24 hours after the first loading dose
Secondary	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.
Secondary	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.
Secondary	incidence of Postoperative nausea and vomiting	incidence rate of PONV	the first 24 hours after surgery
Secondary	incidence rate of respiratory depression	respiratory depression is defined as respiratory rate < 8 and/or SpO2<90%	the first 24 hours after surgery
Secondary	analgesia satisfaction	satisfaction evaluation using 0-100 scale	the first 24 hours after surgery
Secondary	pressing times of postoperative analgesic pump		the first 24 hours after surgery
Secondary	total doses of postoperative analgesic pump		the first 24 hours after surgery