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

NCT05560035 | Unknown

• 1 other identifier: maling20220922
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Metastatic Cancer

Keywords

Cervical cancer; Tumor progression; Lidocaine; Metalloproteinases; vascular endothelial growth factor; epidermal growth factor; thrombospondin2

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• 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

• Resumption of bowel function

  at the end of operation and 48 hours after operation

Other Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Lidocaine

Normal saline

PLACEBO COMPARATOR

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

Other: Normal saline (NS)

Interventions

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.

Lidocaine

Normal saline (NS) OTHER

Patients are received equal volumes of saline intravenously until the end of the surgery

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasm Metastasis; Disease Progression

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09