Pain
Conditions
Interventions
Group HL-1186:Oral HL-1186
Placebo group:Oral placebo
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old <= age <= 75 years old, regardless of gender; (2) 18 kg/m^2 <= BMI <= 30 kg/m^2; (3) Elective abdominal surgery under general anesthesia (such as myomectomy, nephrectomy, hysterectomy, etc.) with expected postoperative pain intensity of moderate to severe; (4) Participants with American Society of Anesthesiologists (ASA) grade I-II; (5) Able to understand the research process and scale use, and communicate effectively with researchers; (6) The participants fully understood the purpose, nature, methods and possible adverse events of the trial, voluntarily participated in the trial, and signed an informed consent.
Exclusion criteria
Exclusion criteria: (1) Previous surgery at the same site that may affect the pain perception at the surgical site as assessed by the researcher; (2) Paresthesia or other pain that may affect postoperative pain evaluation or scale evaluation; (3) Neuropsychiatric diseases, such as depression, anxiety, memory and cognitive impairment, severe sleep disorders, and previous suicidal behavior or suicidal tendency, which may affect the postoperative pain evaluation or scale evaluation; (4) QTcF >=450 ms in men and >=470 ms in women (corrected by Fridericia's method), unstable angina pectoris, myocardial infarction, severe arrhythmia (such as ? degree atrioventricular block), NYHA class >=?, or recurrent asthma attacks during the screening period, etc. Those who were not suitable for inclusion according to the investigator's assessment; (5) Poorly controlled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg (except perioperative period); (6) Sleep apnea syndrome or difficult airway assessed by investigators; (7) Patients with high bleeding risk who were not suitable for the trial according to the evaluation of the investigators, including congenital bleeding diseases (such as hemophilia), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), active bleeding, etc.; (8) Known allergic to any component of the trial intervention drug, allergic to anesthetic/analgesic/antiemetic drugs used in the perioperative period, or allergic history of >=3 substances; (9) The interval between the last use of the banned drug specified in the protocol and the last use of the drug was less than 5 half-lives (indefinite half-lives, elution according to 7 days), which may affect the evaluation of the study drug by the investigator; (10) Abnormal laboratory tests before operation: Platelet count 2.5 × upper limit of normal value, total bilirubin (TBil) > 1.5 × upper limit of normal value; Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (2021 CKD-EPI formula); (11) Positive for human immunodeficiency virus antibody, treponema pallidum antibody and syphilis toluidine red unheated serum test (TRUST), hepatitis B virus surface antigen, or hepatitis C virus antibody; (12) Had a history of heavy drinking (more than 14 units of alcohol per week, 1 unit =14 g of alcohol per week) or drug abuse within 2 years before screening; (13) Pregnant or lactating women (within 1 year after delivery); (14) Participants of childbearing potential had plans to have children/cryopreservation or sperm/egg donation within 6 months after signing informed consent until the last dose of drug, or did not agree to use effective contraceptive methods (complete abstinence, barrier method, contraceptive pill, intrauterine device, or sterilization); (15) Those who had participated in other drug or medical device trials or were participating in other clinical trials within 1 month before screening; (16) Previous history of oral medication dysphagia; (17) The investigator considered that he was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted summed pain intensity at rest differences over 48 h (SPID0-48 h) after the first dose ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time-weighted summed pain intensity at rest differences over 24 h (SPID0-24 h) after the first dose ;The proportion of participants with >=30%, >=50% and >=70% reduction in resting-state numerical rating scale (NRS) at 24h and 48h after the first dose was compared with the baseline.;Time for NRS to decrease >=1 and >=2 points from baseline after the first dose.;The time-weighted summed pain intensity during movement differences from 8h to 24h (SPIDm8-24h) after the first dose , SPIDm8-48h.;The time to first use of rescue therapy, the total number of times used, the cumulative amount used, and the proportion of participants who used rescue therapy within 48 hours after the first dose were analyzed.;The time to response (time to onset of participant perceived pain relief and time to substantial participant perceived improvement in pain) was assessed with the use of a double-stopwatch.; | — |
Countries
China
Contacts
Public ContactSaiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed