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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Experimental | Patients will receive a TAP block using 1.5 mg/kg, 2.0 mg/kg or 2.5 mg/kg of ropivacaine. If there is no LAST (local anesthetic systemic toxicity) in the three subjects of 1.5 mg/kg group, the next three patients will receive 2.0 mg/kg of ropivacaine. Another three patients will receive 2.5 mg/kg of ropivacaine if there is no LAST in the three subjects of 2.0 mg/kg group. All subjects will be administered an i.v. bolus of lidocaine 2.0 mg/kg (given as an infusion for 10 min) after anaesthesia induction, then continuous infusion at 2 mg/kg/h until the end of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine Hydrochloride 10 MG/ML [Naropin] | Drug | According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the total amount on each side. |
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| Measure | Description | Time Frame |
|---|---|---|
| The safety profile of combining ropivacaine and lidocaine | 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. | From administration of ropivacaine or lidocaine to postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of ropivacaine | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunling Jiang, PhD | Contact | 18980601096 | jiangchunling@scu.edu.cn | |
| Li Zhou, PhD | Contact | +8602885423593 | 714549399@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiming Li, PhD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China hospital | Recruiting | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40696274 | Derived | Zhou M, Yu F, Xu Y, Wu J, Luowu L, Tang Q, Hao X, Shao K, Ye M, Bo L, Zhou L, Jiang C. Combining ropivacaine transversus abdominis plane block with intravenous lidocaine infusion in adults undergoing colorectal cancer surgery: an open-label, dose-escalation exploratory trial. BMC Anesthesiol. 2025 Jul 22;25(1):357. doi: 10.1186/s12871-025-03225-5. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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 .
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| From 10 min to 24h after the completion of bilateral TAP block |
| The plasma concentration of 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. | From 10 min to 24h after the initiation of IV lidocaine. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000588 |
| Amines |