Postoperative Pain Of Laparoscopic Surgery
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery
Interventions
SHR0410 Injection（Low Dose）
DRUGPlacebo
Placebo for SHR0410 Injection.
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
SHR0410 injection compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal 3. Male or female 4. Meet the body mass index standard 5. Conform to the ASA Physical Status Classification
Exclusion criteria
1. Subjects with a history of difficult airway 2. Subjects with a history of mental illness 3. Subjects with a history of cognitive impairment epilepsy 4. Subjects with a history of myocardial infarction or unstable angina pectoris 5. Subjects with atrioventricular block or cardiac insufficiency 6. Subjects with a history of ischemic stroke or transient ischemic attack 7. Subjects with poor blood pressure control after medication 8. Subject with a history of substance abuse and drug abuse 9. Abnormal values in liver function 10. Allergic to drugs that may be used during the study 11. Pregnant or nursing women 12. No birth control during the specified period of time 13. Participated in clinical trials of other drugs (received experimental drugs) 14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summed Pain Intensity Difference From 0-24 Hours (SPID0-24) | 0 to 24 hours | Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less | 0 to 24 hours | — |
| Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours | 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours | Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with 0 indicating No Relief, 1 indicating A Little Relief, 2 indicating Some Relief , 3 indicating A Lot of Relief and 4 indicating Complete Relief. |
| Total consumption of remedial analgesics from 0 to 24 hours | 24-hours | — |
| Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18) | 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours | Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity. |
| Investigator Satisfaction Score For Analgesia Treatment | 24-hours | — |
| Numbers of Participants With Abnormal Vital Signs | Day 3 or Day 4 | Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times. |
| Numbers of Participants With Abnormal Laboratory Values | Day 3 or Day 4 | Participants with clinically significant lab values will be compared to those receiving placebo comparator. |
| Participant' Satisfaction Score For Analgesia Treatment | 24-hours | — |
Contacts
Primary ContactQin Liu
Outcome results
None listed