A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

Phase 3

• Conditions: Postoperative Pain Of Laparoscopic Surgery
• Interventions: Drug: SHR0410 Injection; Drug: Placebo

• Registration Number: NCT05459220
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-30
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-12
• Last Update Submitted: 2022-07-12
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 357

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR0410 Injection	SHR0410 Injection（Low Dose）
Treatment group B	SHR0410 Injection	SHR0410 Injection（High Dose）
Treatment group C	Placebo	Placebo for SHR0410 Injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Participant' Satisfaction Score For Analgesia Treatment	24-hours
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 , heart rate (measured by beats per minute) 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.
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.