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

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05560035

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Metastatic Cancer	Drug: Lidocaine Other: Normal saline (NS)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.
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

Arm

Intervention/Treatment

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.

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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