Colorectal Cancer
Conditions
Brief summary
Many studies have confirmed the analgesic effect of intravenous infusion of lidocaine in abdominal surgery. Transversus abdominis plane (TAP) block is also often recommended for abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important components of multimodal analgesia for colorectal surgery. However, both of them are the local anesthetics and the safety of combination is unknown, so investigators design the study to explore the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine infusion in patients undergoing colorectal surgery.
Detailed description
Transversus abdominis plane (TAP) block is often recommended for abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important components of multimodal analgesia for colorectal surgery. However, both of them are the local anesthetics and the safety of combination is unknown, so investigators design the study to explore the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine infusion in patients undergoing colorectal surgery.
Interventions
DRUGRopivacaine Hydrochloride 10 MG/ML [Naropin]
According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the total amount on each side.
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional Study Model: Sequential Assignment According to the principle of the 3+3 design, 3 dose groups with 3 patients in each dose group will be set up. If no dose limited toxicity (DLT) is observed in three groups, a total of 9 patients will be included. If DLT is present in one dose group during dose escalation, 3 cases are amplified in this dose group; if no DLT is observed in 3 cases of amplification, proceed to the next dose group, and so on, up to 18 patients. DLT is defined as local anesthetic systemic toxicity. If blood samples cannot be obtained for any reasons, new patients will be recruited until there are at least 3 patients in each group with blood samples at every time point .
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 65 years; 2. Patients who plan to undergo open/laparoscopic colorectal cancer resection surgery under general anesthesia; 3. American society of Anesthesiologists (ASA) physical status classification system I\ II;
Exclusion criteria
1. Weight less than 40kg or more than 100kg; 2. Defects in the cardiac conduction system (II or III degree atrioventricular block) or cardiac dysfunction (LVEF\<50%); 3. Severe liver dysfunction (ALT, AST, bilirubin 2.5 times higher than normal), renal dysfunction (creatinine clearance rate\<60ml/min); 4. Allergies to experimental drugs; 5. Patients who are unable to communicate; 6. Participating in other clinical researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety profile of combining ropivacaine and lidocaine | From administration of ropivacaine or lidocaine to postoperative 24 hours | To observe signs of LAST, such as dizziness, light-headedness, metallic taste, peri-oral numbness, seizure activity or tinnitus, new-onset ECG irregularities, or intraoperative spike wave of EEG, et al. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentration of ropivacaine | From 10 min to 24h after the completion of bilateral TAP block | Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the completion of bilateral TAP block to measure the plasma ropivacaine concentration. All data will be tested for normality, then investigators will show the central tendency of the blood concentration of ropivacaine for all patients at each time point by means (standard deviation) or median (interquartile interval), the peak time and peak concentration of the blood concentration of ropivacaine. Investigators will also provide trends in the blood concentration of ropivacaine for each patient, and the concentration trend of blood drug concentration in each group of patients according to dose grouping. |
| The plasma concentration of lidocaine | From 10 min to 24h after the initiation of IV lidocaine. | Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the initiation of IV lidocaine to measure the plasma lidocaine concentration. All data will be tested for normality, then we will show the central tendency of the blood concentration of lidocaine for all patients at each time point by means (standard deviation) or median (interquartile interval), and the peak time and peak concentration of the blood concentration of lidocaine. Investigators will also provide trends in the blood concentration of lidocaine for each patient. and the concentration trend of blood drug concentration in each group of patients according to dose grouping. |
Countries
China
Contacts
Primary ContactChunling Jiang, PhD
Backup ContactLi Zhou, PhD
Outcome results
None listed