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

NCT ID: NCT05560035

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-01

Brief Summary

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.

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.

Conditions

Cervical Cancer; Metastatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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.

Normal saline

Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

Group Type: PLACEBO_COMPARATOR

Normal saline (NS)

Intervention Type: OTHER

Patients are received equal volumes of saline intravenously until the end of the surgery

Interventions

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.

Intervention Type: DRUG

Normal saline (NS)

Patients are received equal volumes of saline intravenously until the end of the surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

maling20220922

Identifier Type: -

Identifier Source: org_study_id