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

NCT06006026 | Recruiting

• 1 other identifier: 20201180HX
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The plasma concentration of ropivacaine

  From 10 min to 24h after the completion of bilateral TAP block

• The plasma concentration of lidocaine

  From 10 min to 24h after the initiation of IV lidocaine.

Study Arms (1)

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.

Drug: Ropivacaine Hydrochloride 10 MG/ML [Naropin]

Interventions

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.

ropivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China hospital

Chengdu, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40696274 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Weiming Li, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Li Zhou, PhD

CONTACT

+8602885423593; 714549399@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 .

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 23, 2023
• Study Start: August 28, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 20, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)