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

General Hospital of Ningxia Medical University

Status: Not yet enrolling

Conditions: Metastatic Cancer; Cervical Cancer

Treatments: Other: Normal saline (NS); Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05560035

maling20220922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Other: Normal saline (NS)