Actively Recruiting
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Abdominal Surgery
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-05-28
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of HSK55718 injection for treating postoperative pain in patients undergoing abdominal surgery. This phase II, multicenter, randomized, double-blind, double-dummy study plans to enroll 200 subjects who will be randomly assigned to different treatment groups, including HSK55718 at three dose levels, morphine, or placebo. The study aims to compare these treatments for pain relief after surgery under general anesthesia. Participants will receive one of several treatments: HSK55718 at dose level 1, 2, or 3; morphine; or a placebo. The study is designed with quadruple masking to keep patients, care providers, investigators, and outcome assessors unaware of the assigned treatment. The treatment period covers the postoperative phase following abdominal surgery under general anesthesia. During the study, participants will be monitored for pain intensity differences over 24 hours and other time frames up to 48 hours. Researchers will assess the number of times rescue pain medications are used, time to pain relief, and satisfaction with postoperative analgesia. Safety and efficacy will be evaluated through these measures, and participation involves regular assessments during the immediate postoperative period.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Body Mass Index (BMI) between 18 and 30 kg/m2
- American Society of Anesthesiologists (ASA) physical status grade I to II
- Planned abdominal surgery under general anesthesia
- Within 4 hours after surgery end, Numeric Rating Scale (NRS) pain score of 4 or higher at rest
- Able to understand and voluntarily agree to participate and sign informed consent
You will not qualify if you...
- History of cardiovascular, respiratory, neurological, or psychiatric diseases as specified by the protocol
- Significant abnormal laboratory test results during screening
- History of severe drug allergy or known allergy to the study drug
- Continuous opioid analgesic use for more than 10 days within 3 months before randomization
- Use of medications affecting analgesia with last dose within 5 half-lives before randomization
- History of drug, substance, or alcohol abuse within the past year
- Pregnant or breastfeeding women
- Participation in another drug clinical trial within 3 months before screening
- Presence of any sensory dysfunction
- Presence of any other painful physical condition
- Any other factor deemed by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after surgery
Participants receive study drug or control medication for postoperative pain management following abdominal surgery.
Multiple assessments during 48 hours post-surgery
Trial Site Locations
Total: 2 locations
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
2
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
Y
Yongrui Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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