A Phase 1 interventional study of SYH9089 injection and Ropivacaine hydrochloride in Postoperative Pain, sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 1, Interventional, and Treatment
This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of SYH9089 Injection for postoperative analgesia in these patients.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Patients with a history of to the drug, comparator drug, surgical anesthetics, rescue analgesic drugs, or other drugs that may be used during the trial; 2. Patients with a history of drug abuse/substance use, or those with positive results on a drug abuse screening; 3. Patients with neurological/psychiatric, respiratory, endocrine, hematologic, musculoskeletal, gastrointestinal, cardiovascular systems, or hepatic/renal diseases, judged by the investigator to be unsuitable for the trial; 4. Patients with a history of diabetes mellitus; 5. Patients with a history of myocardial infarction or unstable angina within 1 year prior to randomization; 6. Patients scheduled to undergo purely diagnostic exploratory surgery or palliative tumor resection, judged by the investigator to be unsuitable for the trial; 7. Patients with advanced malignant tumors, judged by the investigator to be unsuitable for the trial; 8. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator; 9. Patients with a history of severe or postoperative nausea or vomiting; 10. Patients scheduled to receive interventions (e.g., intraperitoneal hyperthermic chemotherapy, local/intraperitoneal chemoperfusion, or infrared therapy) during the observation period (randomization to 120h after administration) that may interfere with postoperative pain assessment 11. Use of the following drugs for less than 5 half-lives before randomization (based on the actual drug instructions; or within 7 days prior to randomization if the half-life is unclear) which, in the investigator's judgement, may affect the evaluation of analgesic efficacy. These include, but are not limited to: narcotics (opioids), local anesthetics, non-steroidal anti-inflammatory drugs (NSAIDs), sedative-hypnotics, non-benzodiazepines, sedative anesthetics, (except for topical use), antiepileptics, anxiolytics, antidepressants, as well as Chinese herbal medicines or proprietary Chinese medicines with sedative or analgesic effects; 12. Use of strong CYP1A2 inhibitors for less than 5 half-lives before randomization (e.g., atazanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinylestradiol) ； 13. Subjects with abnormal findings during the screening period (prior to admission) in vital signs, physical examination, 12-lead , or laboratory tests, which in the investigator's judgement make the subject unsuitable for participation in this trial, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SYH9089 injection
Drug: Ropivacaine hydrochloride
Drug: 0.9 % sodium chloride
Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.
Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound.
Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.
Adverse Event Profile
Participants with an Adverse Event through 14 days
Time frame: 14 days
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores
The AUC of NRS-R during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: 0 to 120 hours
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
The AUC of NRS-A during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: 0 to 120 hours
Cumulative use of rescue analgesics during each period
Cumulative amount of rescue analgesics used during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.
Time frame: 0 to 120 hours
Proportion of participants not requiring rescue analgesia in each period
Proportion of participants not requiring rescue analgesia within 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.
Time frame: 0 to 120 hours
Proportion of participants with an NRS-A score ≤ 1 at different time points.
Proportion of participants with an NRS-A score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.
Time frame: 0 to 120 hours
Proportion of participants with an NRS-R score ≤ 1 at different time points.
Proportion of participants with an NRS-R score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.
Time frame: 0 to 120 hours
Time of first morphine rescue analgesia
The time from administration to the first morphine rescue analgesic treatment
Time frame: 0 to 120 hours
Participant's Analgesic Satisfaction Score
Participant satisfaction will be assessed at 120 hours after administration.
Time frame: 0 to 120 hours
Investigator Satisfaction Score
Investigator satisfaction will be assessed at 120 hours after administration
Time frame: 0 to 120 hours
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 83 phase 1 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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CSPC Ouyi Pharmaceutical Co., Ltd. →