Acute postoperative incision pain
Conditions
Interventions
Nerve trunk -0.5% ropivacaine injection concentration group:Before general anesthesia, ultrasound-guided localization was performed, and then 0.5% ropivacaine was injected around the corresponding ner
Nerve trunk -0.375% ropivacaine injection concentration group:Before general anesthesia, ultrasound-guided localization was performed, and then 0.375% ropivacaine was injected around the corresponding
Nerve trunk -0.25% ropivacaine injection concentration group:Before general anesthesia, ultrasound-guided localization was performed, and then 0.25% ropivacaine was injected around the corresponding n
Nerve trunk -0.9% sodium chloride injection concentration group:Before general anesthesia, ultrasound-guided positioning was performed, and then 0.9% sodium chloride injection was injected around the
Local anesthesia -0.375% ropivacaine injection concentration group:Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL
Local anesthesia -0.25% ropivacaine injection concentration group:Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL
Sponsors
Anesthesiology department, Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old (including the critical value), gender is not limited; 2) Clinical diagnosis requires elective general anesthesia for non-head and neck, non-heart (such as laparoscopy; Hip replacement) surgery patients; 3) Weight: 50-90kg (including the critical value); Body mass index (BMI)19 kg/m2 =BMI=30kg/m2, BMI= weight (kg)/ height 2(m2); 4) Meet the American College of Anesthesiologists (ASA) physical status Grade I - III risk assessment standards; 5) Patients fully understand the purpose and requirements of the experiment, agree to participate in the experiment and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) People who are allergic to the test drug, control drug, surgical anesthetic drug, remedial analgesic drug or any component of the drug or similar drugs, or who are allergic or scar constitution; 2) Patients who were dependent on or tolerant to narcotic drugs before randomization; 3) Unable to understand the NRS score and unable to use intravenous analgesia pump PCIA; 4) Patients with severe cardiovascular and cerebrovascular diseases (such as heart failure with NYHA grade III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, refractory hypertension, cerebral infarction, cerebral hemorrhage, etc., severe respiratory system (such as severe bronchial asthma, pulmonary heart disease, etc.) and neurological and psychiatric diseases; 5) There are contraindications to ropivacaine and standard anesthesia procedures; 6) Patients who are complicated with obvious pain and need to use analgesics to treat non-surgical related pain after surgery, which may interfere with postoperative evaluation; 7). Had a history of alcohol abuse or drug abuse within two years prior to randomization; 8) Any of the following drugs or treatments were used during the screening period: 1) the time from the last use of CYP1A2 potent agents (such as azanavir, enoxacin, ethoestradiol, fluvoxamine, etc.) before randomization was shorter than 5 half-lives of the drug; 2) The time between the last use of an opioid or non-opioid analgesic (e.g., acetaminophen, aspirin, indomethacin, diclofenac, parecoxib sodium, etc.) before randomization is shorter than the 5 half-life of the drug or the duration of the drug effect (calculated as the longest); 3) Continuous use of opioid analgesics for any reason for more than 10 days in the 3 months prior to screening; 9). Patients with liver failure; 10). Patients with kidney failure; 11). Patients at high blood risk, including those with congenital bleeding disorders (such as hemophilia), thrombocytopenia (platelet count below 30×109/L), abnormal platelet function, or any clinically significant active bleeding; 12) Subjects who have any other factors that the investigator deems inappropriate to participate in this clinical study that may affect the test results or increase the risk of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative dosage of sufentanil was calculated from 0 h to 72 h after receiving the test drug; | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the intensity time curve (AUC) of incision resting pain at 0-12 h, 0-24 h, 0-36 h, 0-48 h, 0-60 h, and 0-72 h after awakening of the subjects;Cumulative dosage of rescue analgesics/kg body weight for incisional pain at 0-12 h, 0-24 h, 0-36 h, 0-48 h, and 0-60 h after awakening;The total cumulative dosage of rescue analgesics during 0-12 h, 0-24 h, 0-36 h, 0-48 h, 0-60 h, and 0-72 h after awakening;Time to first request for rescue analgesic for incisional pain;The proportion of subjects who did not use rescue analgesics for incisional pain within 72 h after emergence;Subjects' pain satisfaction;The time of first postoperative gastrointestinal ventilation; | — |
Countries
China
Contacts
Public ContactWang Saiying
Third Xiangya Hospital, Central South University
Outcome results
None listed