Pain After Abdominal SurgeryPhase 2NCT07491146
Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain
A Phase 2 study testing Low dose HSK55718, Medium Dose HSK55718 and High dose HSK55718 in people with Pain After Abdominal Surgery, run by Yingyong Zhou,MD,PhD at 2 sites in China.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain After Abdominal Surgery
- What is being tested?
- Low dose HSK55718, Medium Dose HSK55718 and High dose HSK55718
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 23 May 2026to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand, voluntarily participate in this study and sign the informed consent;
- Age ≥18 years old, both sexes;
- Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
- 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;
- NRS≥4 in the resting state at any time within 4 hours after the end of surgery;
- Be able to comply with the follow-up schedule and other program requirements;
- Participants agreed to use highly effective contraception for the entire duration of the study, from the time they signed the ICF until 3 months after the last dose of the investigational product was administered.
Who cannot join
- 1. Disease status
- History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
- Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or history of NYHA class II or above;
- Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear, and severe respiratory infection within the last 2 weeks before screening;
- History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of schizophrenia, mania, psychosis, long-term use of psychotropic drugs, cognitive dysfunction, etc. Depression, anxiety, epilepsy history, etc.
- cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria:
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- Blood routine: white blood cell count < 3.0×109/L; Platelet count < 80×109/L; Hemoglobin < 70 g/L; (2) Coagulation function: prothrombin time (PT) prolongation exceeded the upper limit of normal value for 3 seconds; Activated partial thromboplastin time (APTT) prolonged more than 10 seconds; (3) Liver and kidney function: alanine aminotransferase and/or aspartate aminotransferase > 2×ULN; Total bilirubin > 2×ULN; Serum creatinine > 1.5×ULN; (4) Fasting blood glucose ≥11.1 mmol/L; (5) Participants who did not receive regular antihypertensive treatment or whose blood pressure was poorly controlled (systolic blood pressure ≥160mmHg or ≤90mmHg at screening, and/or diastolic blood pressure ≥100mmHg or ≤60mmHg at screening, excluding abnormalities during anesthesia from admission to PACU and during recovery from anesthesia); (6) QTc >450ms in men and >470ms in women (QTc was calculated with Fridericia's formula); (7) Transcutaneous oxygen saturation (SpO2) <90% during screening (excluding abnormal anesthesia from admission to PACU and anesthesia recovery period); (8) Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody were positive during the screening period; 3. Medication use
- Patients with a history of severe drug allergy, or other drugs that may be used during the trial, such as anesthetics propofol/sevoflurane, rocuronium, antiemetic drugs, or drugs and their excipients;
- Taking opioid analgesics for any reason for more than 10 consecutive days within 3 months before randomization;
- Drugs that may affect the evaluation of efficacy if the time interval between the last administration of the drug and randomization is less than five half-lives of the drug, including but not limited to the following drugs: Selective α2-adrenoceptor agonists, opioid agonists/antagonists, non-steroidal anti-inflammatory drugs, sedative drugs, monoamine oxidase inhibitors, glucocorticoids, antiepileptic, anxiolytic, antidepressant and other antipsychotic drugs. Refer to the list of banned drugs for specific types.
- Use of a strong inducer or inhibitor of CYP3A within 14 days or 5 half-lives before the first dose of the investigational drug, whichever is longer; 4: Others
- Having a history of drug abuse, drug abuse and/or alcohol abuse in the past year, with alcohol abuse defined as drinking an average of > 2 units of alcohol per day (1 unit =360mL of 5% beer or 45mL of 40% liquor or 150mL of wine); (2) Positive results of drug abuse screening during the screening period; (3) Pregnant or lactating women; (4) Had participated in other drug clinical trials (defined as receiving investigational drug or placebo) within 3 months before the screening period; (5) Any sensory dysfunction that may interfere with the ability to assess postoperative pain according to the investigator's judgment; (6) Painful physical conditions that may interfere with postoperative evaluation according to the investigator's judgment; (7) Participants had medical complications during the operation and were not suitable for further study according to the investigator's judgment; (8) Participants with any other factors considered by the investigator to be ineligible for the clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha, Hunan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Mengchang yang, PhD, 8618140049936, ymc681@126.com
About this study
Official title: To Evaluate the Efficacy and Safety of HSK55718 for Injection in Patients With Abdominal Postoperative Pain: a Multicenter, Randomized, Double-blind, Placebo/Positive Control Phase II Clinical Trial.
A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
- Conditions
- Pain After Abdominal Surgery
- Being tested
- Low dose HSK55718, Medium Dose HSK55718, High dose HSK55718, Morphine, Normal saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose HSK55718Drug
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours
Medium Dose HSK55718Drug
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours.
High dose HSK55718Drug
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours
MorphineDrug
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours
Normal saline solutionDrug
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| 15mg/7.5mg GHSK55718 group | Experimental | After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours Receives: Drug: Low dose HSK55718 |
| 60mg/30mg GHSK55718 group | Experimental | After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then30mg HSK55718 injection or normal saline was given intermittently every 6 hours Receives: Drug: Medium Dose HSK55718 |
| 120mg/60mg GHSK55718 group | Experimental | After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours Receives: Drug: High dose HSK55718 |
| Positive control group | Active comparator | After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours Receives: Drug: Morphine |
| Placebo control group | Placebo comparator | After the postoperative NRS pain score ≥4, normal saline was administered intravenously and then intermittently every 6h Receives: Drug: Normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest
The time-weighted summed pain intensity differences during 0-24 hours (SPID0-24 h) at rest after the first dose
Measured: From administration until 24 hours after administration
Secondary outcomes (8)
the time-weighted summed pain intensity differences (SPID) at rest
The time-weighted summed pain intensity differences during 0-12h, 12-24h, 24-48h, and 0-48h (SPID0-12h、SPID12-24h、SPID24-48h、SPID0-48h) at rest after the first dose
Measured: From administration until 12 hours, 48 hours after administration, from 12 hours to 24 hours and 24 hours to 48 hours after administration.
Pain intensity differences (PID)
The rest pain intensity difference (PID) was calculated at each scoring time point after the first dose, and PID was the difference between the NRS score at each time point and the baseline NRS score
Measured: From administration until 48 hours after administration
The proportion of NRS pain score ≤3
Measured: From administration until 48 hours after administration
Time to onset
Measured: From administration until 12 hours after administration
Cumulative use of rescue analgesics during each period
Measured: From the time of administration to 24 hours and 48 hours after administration
Time of first sufentanil rescue analgesia
Measured: From administration until 48 hours after administration
Proportion of rescue analgesia
Measured: From administration until 48 hours after administration
Postoperative analgesia satisfaction score
At 24 hours after the end of the study, participants recalled the analgesic effect of the postoperative analgesia and rated their satisfaction on a scale of 0 to 10, with 0 indicating dissatisfied and 10 very satisfied.
Measured: From administration until 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingyong Zhou,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingyong Zhou,MD,PhD, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491146
- Sponsor's protocol ID
- HSK55718-201
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of HSK55718 for Injection in Patients With Abdominal Postoperative Pain: a Multicenter, Randomized, Double-blind, Placebo/Positive Control Phase II Clinical Trial.
- ClinicalTrials.gov ID
- NCT07491146
- Acronym / sponsor ID
- HSK55718-201
- Conditions
- Pain After Abdominal Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yingyong Zhou,MD,PhDUniversity, hospital or other
- Study start
- 23 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 15mg/7.5mg GHSK55718 group | Experimental | Drug: Low dose HSK55718After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours |
| 60mg/30mg GHSK55718 group | Experimental | Drug: Medium Dose HSK55718After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then30mg HSK55718 injection or normal saline was given intermittently every 6 hours |
| 120mg/60mg GHSK55718 group | Experimental | Drug: High dose HSK55718After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours |
| Positive control group | Active comparator | Drug: MorphineAfter the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours |
| Placebo control group | Placebo comparator | Drug: Normal saline solutionAfter the postoperative NRS pain score ≥4, normal saline was administered intravenously and then intermittently every 6h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand, voluntarily participate in this study and sign the informed consent;
- Age ≥18 years old, both sexes;
- Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
- 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;
Key exclusion criteria (12 listed)
- 1. Disease status
- History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
- Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or history of NYHA class II or above;
- Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear, and severe respiratory infection within the last 2 weeks before screening;
- History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of schizophrenia, mania, psychosis, long-term use of psychotropic drugs, cognitive dysfunction, etc. Depression, anxiety, epilepsy history, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose HSK55718NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours | Drug | 15mg/7.5mg GHSK55718 group |
| Medium Dose HSK55718NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours. | Drug | 60mg/30mg GHSK55718 group |
| High dose HSK55718NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours | Drug | 120mg/60mg GHSK55718 group |
| MorphineNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours | Drug | Positive control group |
| Normal saline solutionNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours | Drug | Placebo control group |
Primary outcome
The time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest
Time frame: From administration until 24 hours after administration
The time-weighted summed pain intensity differences during 0-24 hours (SPID0-24 h) at rest after the first dose
8 secondary outcomes
the time-weighted summed pain intensity differences (SPID) at rest
Time frame: From administration until 12 hours, 48 hours after administration, from 12 hours to 24 hours and 24 hours to 48 hours after administration.
Pain intensity differences (PID)
Time frame: From administration until 48 hours after administration
The proportion of NRS pain score ≤3
Time frame: From administration until 48 hours after administration
Time to onset
Time frame: From administration until 12 hours after administration
Cumulative use of rescue analgesics during each period
Time frame: From the time of administration to 24 hours and 48 hours after administration
Time of first sufentanil rescue analgesia
Time frame: From administration until 48 hours after administration
Proportion of rescue analgesia
Time frame: From administration until 48 hours after administration
Postoperative analgesia satisfaction score
Time frame: From administration until 48 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose HSK55718, Medium Dose HSK55718 and High dose HSK55718 in people with Pain After Abdominal Surgery, run by Yingyong Zhou,MD,PhD at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saiying Wang, PhD (+86073188618152, zwyhyll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest (time frame: From administration until 24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.