The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery

Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia

The purpose of this study is to investigate the efficacy of intravenous lidocaine on THBS2, MMPs and VEGF-C in serum in cervical cancer patients undergoing radical hysterectomy under general anesthesia.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer; Metastatic Cancer
• Intervention / Treatment: Other: Normal saline (NS); Drug: Lidocaine

Detailed Description

The surgical stress response to tumour removal causes bloodstream release of a variety of pro-inflammatory cytokines and other molecules which may affect perioperative immune response and other conditions conducive to residual tumour cell survival that could later emerge as clinical recurrences or metastasis. Lidocaine has analgesic and anti-inflammatory effects, and may also have specific anticancer properties.

Blood serum expression of these molecules (metalloproteinases, vascular endothelial growth factor [VEGF], epidermal growth factor）, play a important role in the metastatic process and tumor progression. lidocaine could affect the course and growth of metastatic tumors by changing the cancer cells, the tumor microenvironment, or both.

We tested the hypothesis that women undergoing cervical cancer resection with these techniques (intravenous lidocaine) have reduced postoperative serum expression of metastasis biomarkers, and may change the outcomes of cancer patients.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients were scheduled by following cervical cancer surgery under general anesthesia
• Aged 18-65 years
• ASA physical status Ⅱ-Ⅲ

Exclusion Criteria:

• Severe heart, pulmonary, hepatic and renal insufficiency
• History of neurological diseases
• Autoimmune disorders
• Antiarrhythmic drugs (amiodarone, verapamil, propafenone)
• Patients' decision to withdraw anytime from the study, and refusal to participate before surgery and at postoperative follow-up
• Allergy to one of the used medications
• Psychiatric illness, psychological disorder, and drug or alcohol abuse
• Unwillingness to comply with the protocol or procedures
• Preoperative treatment of chemotherapy, radiation, NSAID and hormonal therapy
• History of anesthesia and surgery in two weeks
• Coexisting other cancers and intraoperative presence of liver metastasis
• Perioperative treatment of blood transfusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline; Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.	Other: Normal saline (NS); Patients are received equal volumes of saline intravenously until the end of the surgery
Experimental: Lidocaine; Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg for the next 22h.	Drug: Lidocaine; Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the frst hour, 1.5 mg/kg for the second hour, 0.7 mg/kg for the next 22h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery	Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation	Baseline and 48 hours after operation
Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery	Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation	Baseline and 48 hours after operation
Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery	Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation	Baseline and 48 hours after operation
Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery	Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation	Baseline and 48 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively	the severity of pain measured using Visual Analogue Score (VAS) on postoperative days at the moment, 12, 24 and 48 hours after surgery	at the end of operation and 48 hours after operation
Resumption of bowel function	Record the time to first flatus and the first defecation	at the end of operation and 48 hours after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and anesthetic data, as well as surgical data from each enrolled patient, will be registered on a data collection sheet.	Record the patients demographic and the data of anesthetic and surgical, analysis the connection with primary outcomes	Baseline and 48 hours after operation

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Lidocaine; Cervical cancer; vascular endothelial growth factor; Metalloproteinases; epidermal growth factor; Tumor progression; thrombospondin2
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: maling20220922

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No