A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Pain

Treatments: Drug: SHR8554 Injection and SHR0410 Injection; Drug: SHR8554 Injection and Placebo for SHR0410 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05470049

SHR8554/SHR0410-201

Details and patient eligibility

About

The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Random blood glucose ≥11.1mmol/L
6. Subjects with abnormal liver function
7. allergies to opioids and other medications that may be used during the trial
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

Treatment group A: SHR8554 Injection and SHR0410 Injection

Experimental group

Treatment:

Drug: SHR8554 Injection and SHR0410 Injection

Treatment group B: SHR8554 Injection and SHR0410 Injection

Experimental group

Treatment:

Drug: SHR8554 Injection and SHR0410 Injection

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Placebo Comparator group

Treatment:

Drug: SHR8554 Injection and Placebo for SHR0410 Injection