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Trial Title:
The Safety of Ropivacaine TAP Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery
NCT ID:
NCT06006026
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Ropivacaine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
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 .
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ropivacaine Hydrochloride 10 MG/ML [Naropin]
Description:
According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the
total amount on each side.
Arm group label:
ropivacaine
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Xu, MD
Start date:
August 28, 2023
Completion date:
May 20, 2024
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06006026
