Pain
Conditions
Brief summary
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery
Interventions
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia abdominal surgery 3. Conform to the ASA Physical Status Classification
Exclusion criteria
1. Subjects with a history of difficult airway 2. Subjects with a history of reflux esophagitis 3. Subjects with a history of mental illness 4. Subjects with poor blood pressure control 5. Transcutaneous oxygen saturation (SpO2) \<90% 6. Random blood glucose ≥11.1mmol/L 7. Subjects with abnormal liver function 8. allergies to opioids and other medications that may be used during the trial 9. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 24 Hours | 24-hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours | 6-hours、12-hours、18-hours、12-18 hours | time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、18 、12-18 hours) to yield values on the 0-10 NPRS. |
| Time of first use of remedial analgesic medication | 24-hours | The first time to use parecoxib sodium for injection |
| Cumulative use of remedial analgesics from 0h to 24h | 24-hours | Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection |
| Participant ' satisfaction score for analgesia treatment | 24-hours | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied. |
| Investigator satisfaction score for analgesia treatment | 24-hours | Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied. |
Countries
China
Outcome results
None listed