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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | 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. |
|
| Normal saline | Placebo Comparator | Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009362 | Neoplasm Metastasis |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline (NS) | Other | Patients are received equal volumes of saline intravenously until the end of the surgery |
|
| Resumption of bowel function |
Record the time to first flatus and the first defecation |
| at the end of operation and 48 hours after operation |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |