Postoperative pain
Conditions
Interventions
Test Group (low dose group):Long acting ropivacaine injection (10 mL: 200 mg), once every 3.0 cm between adjacent injection points
Test Group (Middle dose group):Long acting ropivacaine injection (10 mL: 200 mg), once every 2.5 cm between adjacent injection points
Test Group (High dose group):Long acting ropivacaine injection (10 mL: 200 mg), once every 2.0 cm between adjacent injection points
Control Group:Ropivacaine hydrochloride injection, naloxone (10 mL: 100 mg)
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (including the cut-off value), regardless of gender; 2. For patients who were clinically diagnosed as needing elective laparoscopic surgery under general anesthesia (including gynecological laparoscopic surgery, liver laparoscopic surgery, and gallbladder laparoscopic surgery), 3 cm = 3 cm; 3. Weight: 50kg-90kg (including the critical value); Body mass index (BMI): 19 kg/m2<=BMI<=30 kg/m2; BMI=Weight(kg)/height2(m2); 4. Meeting American College of Anesthesiologists (ASA) Physical status Grading I-II risk assessment criteria; 5. The patients fully understood the purpose and requirements of the trial, agreed to participate in the trial and voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient is allergic to the test drug, control drug, surgical anesthetic drug, remedial analgesic drug or any component of the drug or similar drug, or has allergic constitution or scar constitution; 2. Patients with narcotic drug dependence or tolerance to oxycodone hydrochloride injection before randomization; 3. Unable to understand VAS score and unable to use intravenous analgesic pump PCIA; 4. Patients with cardiovascular, cerebrovascular, respiratory, nervous and mental diseases; 5. There are contraindications to ropivacaine, oxycodone, and standard anesthesia procedures; 6. The co-morbiditis accompanied by significant pain and the need for postoperative analgesics to treat pain associated with non-open surgery may interfere with postoperative evaluation; 7. History of alcohol abuse and drug abuse within 2 years before randomization; 8. Any of the following drugs or treatments were used during the screening period: (1) Before randomization, the time from the last administration of CYP1A2 strong inhibitor (such as atazanavir, enoxacin, ethinylestradiol, fluvoxamine,etc.) was less than 5 half-lives of the drug; (2) The time between randomization and the last use of an opioid or non-opioid analgesic (such as acetaminophen, aspirin (daily dose >100mg), indomethacin, diclofenac, parecoxib sodium and other non-steroidal anti-inflammatory drugs) was less than the 5-half-life of the drug or the duration of the drug effect; (3) Opioid analgesics were used continuously for any reason for more than 10 days in the 3 months prior to screening; (4) Drugs with uncertain half-life affecting analgesic effect were used within 14 days before randomization, or use drugs that affect analgesic effect before randomization, and the time of the last use is less than 5 half-lives from the random time(the actual drug instruction shall prevail), including but not limited to sedative hypnotics (benzodiazepines (triazolam, diazepam, midazolam, etc.), non-benzodiazepines (zolpidem, zopiclone, zaleplon, etc.), sedative anesthetics (sevoflurane, anesthetic ether, nitrous oxide, sodium thiopental, ketamine, etomidate, etc.), glucocorticoids (dexamethasone hydrochloride, methylprednisolone, etc.), anti-epileptic (carbamazepine, valproate, etc.), anxiolytics (clozapine, diazepam, etc.),antidepressants (imipramine, amitriptyline, etc.), and have analgesic, sedative effect of Chinese herbal medicine or Chinese patent medicine; (5) It is expected that anti-tumor drugs and treatments, including but not limited to chemotherapy drugs, targeted drugs and Chinese herbal medicines, will be used from 14 days before randomization to the end of the follow-up period; 9. Hepatitis C antibodies were detected by virology during the screening period (HCVAb), syphilis antibody, the human immunodeficiency virus (HIV) antibody test was positive; 10. Abnormal liver function: Liver function grade B or above, or ALT and/or AST > 2 x ULN, or TBIL >= 1.5 x ULN; 11. Severe kidney disease,serum creatinine > 176 µmol/L, or received dialysis treatment within 28 days before surgery; 12. Patients with high blood risk, these include patients with congenital bleeding disorders (e.g., hemophilia), patients with thrombocytopenia (platelet count less than 30 x 10^9 per liter), patients with platelet dysfunction, or patients with clinically significant active bleeding of any kind; 13. Patients who had participated in other clinical studies within the previous 3 months were screened; 14. Pregn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative use of remedial analgesics for incisional pain/kg body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incision resting pain intensity - time area under curve (AUC);The accumulation of a remedial analgesic for incisional pain dosage/kg body weight;Total cumulative use of remedial analgesics measure/kg weight;The time to first request for a remedial analgesic for incisional pain after dosing;Proportion of subjects who did not use remedial analgesics for incisional pain;electrocardiograph;Blood routine examination;Blood biochemical test;Post-administration adverse events; | — |
Countries
China
Contacts
Public ContactChi Ping
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed