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

Sponsor

West China Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006026

Collaborator

(none)

Enrollment

Arm

1.5

Anticipated Duration (Months)

Study Details

Study Description

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 we design the study to explore the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine infusion in patients undergoing colorectal surgery.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Ropivacaine Hydrochloride 10 MG/ML [Naropin]	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

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 .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 .

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ropivacaine 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.	Drug: Ropivacaine 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.

Arm

Intervention/Treatment

Experimental: ropivacaine

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.

Drug: Ropivacaine 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.

Outcome Measures

Primary Outcome Measures

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

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 we 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. We 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. We 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged between 18 and 65 years;
Patients who plan to undergo open/laparoscopic colorectal cancer resection surgery under general anesthesia;
American society of Anesthesiologists (ASA) physical status classification system I~II;

Exclusion Criteria:

Weight less than 40kg or more than 100kg;
Defects in the cardiac conduction system (II or III degree atrioventricular block) or cardiac dysfunction (LVEF<50%);
Severe liver dysfunction (ALT, AST, bilirubin 2.5 times higher than normal), renal dysfunction (creatinine clearance rate<60ml/min);
Allergies to experimental drugs;
Patients who are unable to communicate;
Participating in other clinical researchers.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

West China Hospital

Investigators

Principal Investigator: Weiming Li, PhD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chunling Jiang, Professor, West China Hospital

ClinicalTrials.gov Identifier:

NCT06006026

Other Study ID Numbers:

20201180HX

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Ropivacaine

Study Results

No Results Posted as of Aug 23, 2023