The Safety of Ropivacaine TAP Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Ropivacaine Hydrochloride 10 MG/ML [Naropin]

• Registration Number: NCT06006026
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-23
• Study Start: 2023-08-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ropivacaine	Ropivacaine Hydrochloride 10 MG/ML [Naropin]	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

West China hospital; 🇨🇳 Chengdu, China