Cervical Cancer, Metastatic Cancer
Conditions
Keywords
Cervical cancer, Tumor progression, Lidocaine, Metalloproteinases, vascular endothelial growth factor, epidermal growth factor, thrombospondin2
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.
Interventions
DRUGLidocaine
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.
OTHERNormal saline (NS)
Patients are received equal volumes of saline intravenously until the end of the surgery
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed