Postoperative pain
Conditions
Interventions
IIa - Positive control group :Administration of intercostal nerve block with levobupivacaine hydrochloride injection (0.325%, 20 mL)
IIa - LL10 group :Administration of intercostal nerve block with LL10 (1.258%/0.325%, 20mL)
IIb - Positive control group :Administration of transversus abdominis plane block with levobupivacaine hydrochloride injection (0.188%, 80 mL)
IIb - low-dose group of LL10 :Administration of transversus abdominis plane block with LL10 (0.726%/0.188%, 80 mL)
IIb - high-dose group of LL10 :Administration of transversus abdominis plane block with LL10 (0.864%/0.223%, 80 mL)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At the time of screening,age 18–75 years(including the boundary value), and the gender is not limited; 2. When screening, male weight >=50.0 kg , female weight >=45.0 kg, and BMI 18–28 kg/m^2 (including the boundary value); 3. American Society of Anesthesiologists (ASA) grades I - II; 4. Scheduled for one of the following procedures under general anesthesia: (1).Single-port thoracoscopic lobectomy, expected duration 1–3 hours (Study IIa); (2).Laparoscopic colon or rectal resection, expected duration 2–5 hours (Study IIb); 5) Fully understanding the purpose, procedures (e.g., pain assessment, PCA pump use) and requirements of the trial, and signing the informed consent form approved by the ethics committee;
Exclusion criteria
Exclusion criteria: 1. History of malignant hyperthermia or anesthesia-related adverse events; 2.Expected difficult intubation or ventilation; 3.Hypersensitivity or contraindication to the investigational drug, protocol-specified medications, rescue analgesics, or amide-type local anesthetics; 4.Concomitant pain conditions affecting postoperative pain assessment (e.g., non-surgical site pain lasting =3 months continuously or =6 months intermittently) or sensory disorders like hyperalgesia; 5.Screening lab results meeting any of the following: - ANC = 1.5 × ULN; - TBIL >= 1.5 × ULN; - Cr >= 1.5 × ULN; - PT > ULN + 3s or APTT > ULN + 10s; 6.Positive for HBsAg, HCV Ab, HIV Ab, or TP Ab; 7.Need for non-protocol local anesthesia or analgesia during the study; 8.Participation in another clinical trial within 4 weeks before dosing, or use of pain-affecting drugs/treatments within 3 days before dosing; 9.Surgery within 1 month before dosing or planned surgery during the study other than the index procedure; 10.History of psychotropic or anesthetic drug abuse; 11.Drug dependence or alcohol misuse within 1 year before dosing (alcohol misuse: >14 standard drinks/week; 1 drink = 150 mL wine, 360 mL beer, or 45 mL spirits); 12.Pregnant or breastfeeding women; individuals of reproductive potential not using contraception; or planning pregnancy within 3 months after study (including males); 13.other conditions judged by the investigator to be inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effects indicators:NRS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effects indicators: Morphine equivalent of postoperative rescue analgesics;Clinical effects indicators: Score of postoperative analgesia satisfaction;Safety assessment indicators: 12-lead electrocardiogram;Safety assessment indicators: vital signs;Safety assessment indicators: Laboratory examinations;Safety assessment indicators:Physical examination;Safety assessment indicators: Adverse event;Plasma concentration of levobupivacaine;Plasma concentration of 2-hydroxyethyl lidocaine aminium bromide; | — |
Countries
China
Contacts
Public ContactTao Zhu
West China Hospital, Sichuan University
Outcome results
None listed