Pain
Conditions
Brief summary
The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following Orthopedic surgery
Interventions
Sponsors
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent 2. BMI≥18.0 kg/m2 and ≤28.0 kg/m2 3. ASA I to II 4. Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
Exclusion criteria
1. Opioid allergy 2. Nervous system diseases (e.g. epilepsy) 3. Psychiatric disorders (e.g. depression) 4. History of difficult airways 5. Random blood glucose ≥11.1 mmol/L 6. Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg 7. Abnormal pulse oxygen saturation (SpO2 \<92 %) 8. Abnormal liver function or renal function 9. Used agents that could affect the analgesic response 10. Used agents that could affect drug metabolism 11. Has previously participated in another YZJ-4729 clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sum of pain intensity differences in pain score over 48 hours at rest | 48 hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time of first using of rescue analgesics | 0-48 hours | — |
| The proportion of subjects using rescue analgesics | 0-48 hours | — |
| The number of times for rescue analgesics using | 0-48 hours | — |
| The cumulative dose used of rescue analgesics | 0-48 hours | — |
| The resting Sum of Pain Intensity Differences Over 12,24,24~48 | 0-48 hours | — |
| The active Sum of Pain Intensity Differences Over 12,24,48,24~48 | 0-48 hours | — |
| Participant satisfaction scores for analgesia treatment | 48 hours | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied |
| Investigator satisfaction scores for analgesia treatment | 48 hours | Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied |
Countries
China
Outcome results
None listed