Clinical trial NCT05560035: The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery
Official title: Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Metastatic Cancer
Keywords: Cervical cancer
Tumor progression
Lidocaine
Metalloproteinases
vascular endothelial growth factor
epidermal growth factor
thrombospondin2
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery
timeFrame: Baseline and 48 hours after operation
measure: Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery
timeFrame: Baseline and 48 hours after operation
measure: Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery
timeFrame: Baseline and 48 hours after operation
measure: Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery
timeFrame: Baseline and 48 hours after operation
Secondary outcomes:
measure: Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively
timeFrame: at the end of operation and 48 hours after operation
measure: Resumption of bowel function
timeFrame: at the end of operation and 48 hours after operation
Other outcomes:
measure: Demographic and anesthetic data, as well as surgical data from each enrolled patient, will be registered on a data collection sheet.
timeFrame: Baseline and 48 hours after operation
Locations:
Study officials:
References: