New injection could ease pain after belly surgery
NCT ID NCT07491146
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tests a new drug called HSK55718 for pain after abdominal surgery. About 200 adults will receive either the drug, a placebo, or an active comparator. The goal is to see if it reduces pain over 24 hours and to check its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK55718 injection
- What this could lead to
- If successful, this could provide a new painkiller option for people recovering from abdominal surgery, potentially with fewer side effects than current treatments.
- What could go wrong
- This is an early Phase 2 trial with only 200 participants. It may not show clear benefit or could have unexpected side effects. Results may not apply to all types of surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Fully understand, voluntarily participate in this study and sign the informed consent; 2. Age ≥18 years old, both sexes; 3. Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia; 4. 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2 5. American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ; 6. NRS≥4 in the resting state at any time within 4 hours after the end of surgery; 7. Be able to comply with the follow-up schedule and other program requirements; 8. 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. Exclusion Criteria: 1\. Disease status 1. History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening; 2. 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; 3. 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; 4. 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. 5. cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria: (1) 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 1. 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; 2. Taking opioid analgesics for any reason for more than 10 consecutive days within 3 months before randomization; 3. 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. 4. 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 (1) 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, China
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The Third Xiangya Hospital of Central South University, Changsha, hunan
RECRUITINGChangsha, Hunan, China
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