Pain relief after abdominal surgery: testing HSK55718 against morphine and placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind study enrolling about 200 adults who have undergone abdominal surgery under general anesthesia. Participants will be assigned to receive one of three treatments: HSK55718 at one of three dose levels, placebo, or morphine, in a double-dummy design. The trial aims to compare pain relief and safety outcomes in the early postoperative period, with NRS pain scores used to guide assessments. Eligible participants must be adults with BMI between 18 and 30, ASA I–III, and active pain within 4 hours after surgery. The study will be conducted at two Chinese hospitals, with lead sponsor Haisco Pharmaceutical Group Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Sichuan Provincial People's Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yongrui Wang
• Email: wangyr@haisco.com
• Phone: 028-67258779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.