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

Primary Purpose

Cervical Cancer, Metastatic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
Normal saline (NS)
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical cancer, Tumor progression, Lidocaine, Metalloproteinases, vascular endothelial growth factor, epidermal growth factor, thrombospondin2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Lidocaine

    Normal saline

    Arm Description

    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 administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    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
    Resumption of bowel function
    Record the time to first flatus and the first defecation

    Full Information

    First Posted
    September 26, 2022
    Last Updated
    September 28, 2022
    Sponsor
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05560035
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Metastatic Cancer
    Keywords
    Cervical cancer, Tumor progression, Lidocaine, Metalloproteinases, vascular endothelial growth factor, epidermal growth factor, thrombospondin2

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Normal saline (NS)
    Intervention Description
    Patients are received equal volumes of saline intravenously until the end of the surgery
    Primary Outcome Measure Information:
    Title
    Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery
    Description
    Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
    Time Frame
    Baseline and 48 hours after operation
    Title
    Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery
    Description
    Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
    Time Frame
    Baseline and 48 hours after operation
    Title
    Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery
    Description
    Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
    Time Frame
    Baseline and 48 hours after operation
    Title
    Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery
    Description
    Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
    Time Frame
    Baseline and 48 hours after operation
    Secondary Outcome Measure Information:
    Title
    Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively
    Description
    the severity of pain measured using Visual Analogue Score (VAS) on postoperative days at the moment, 12, 24 and 48 hours after surgery
    Time Frame
    at the end of operation and 48 hours after operation
    Title
    Resumption of bowel function
    Description
    Record the time to first flatus and the first defecation
    Time Frame
    at the end of operation and 48 hours after operation
    Other Pre-specified Outcome Measures:
    Title
    Demographic and anesthetic data, as well as surgical data from each enrolled patient, will be registered on a data collection sheet.
    Description
    Record the patients demographic and the data of anesthetic and surgical, analysis the connection with primary outcomes
    Time Frame
    Baseline and 48 hours after operation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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