Clinical trial NCT06006026: The Safety of Ropivacaine TAP Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery
Official title: The Safety of Ropivacaine Transversus Abdominis Plane Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery: a Single Center, Open Label Dose Escalation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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

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.

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.

Primary outcomes:
measure: The safety profile of combining ropivacaine and lidocaine
timeFrame: From administration of ropivacaine or lidocaine to postoperative 24 hours
Secondary outcomes:
measure: The plasma concentration of ropivacaine
timeFrame: From 10 min to 24h after the completion of bilateral TAP block
measure: The plasma concentration of lidocaine
timeFrame: From 10 min to 24h after the initiation of IV lidocaine.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China hospital
Study officials:
affiliation: West China Hospital
name: Weiming Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: