A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK55718 dose level 1, HSK55718 dose level 2, HSK55718 dose level 3, placebo.
- Who it may be relevant to
- Registry conditions: Pain After Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery
Overview
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.
Interventions
- Drug HSK55718 dose level 1
Patients administrated with HSK55718 at dose level 1 - Drug HSK55718 dose level 2
Patients administrated with HSK55718 at dose level 2 - Drug HSK55718 dose level 3
Patients administrated with HSK55718 at dose level 3 - Drug placebo
Patients administrated with placebo - Drug morphine
Patients administrated with morphine
Primary outcome measures
- Sum of Pain Intensity Differences (SPID) [Time frame: 48hours]
Secondary outcome measures (4)
- Sum of Pain Intensity Differences (SPID) in other time frame [Time frame: 0-12 hours, 12-24 hours, 24 hours, 24-48 hours]
- Number of times rescue analgesic medications were administered. [Time frame: 48 hours]
- Time to Pain Relief [Time frame: 0-48 hours]
- Postoperative Analgesia Satisfaction Score [Time frame: 48 hours]
Eligibility criteria
Inclusion criteria
Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery under general anesthesia; Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; Fully understand and voluntarily participate this trial, and sign the informed consent form;
Exclusion criteria
A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
Clinically significant abnormalities in laboratory tests during the screening period.
A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.
Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07551739 · HSK55718-202