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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05560035
• Other study ID #: maling20220922
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2022
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Cervical Cancer
• Metastatic Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Other:
• Normal saline (NS)
Patients are received equal volumes of saline intravenously until the end of the surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Resumption of bowel function	Record the time to first flatus and the first defecation	at the end of operation and 48 hours after operation