Cervical CancerNCT05560035
The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery
A study testing Lidocaine and Normal saline (NS) in people with Cervical Cancer and Metastatic Cancer, run by General Hospital of Ningxia Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Metastatic Cancer
- What is being tested?
- Lidocaine and Normal saline (NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were scheduled by following cervical cancer surgery under general anesthesia
- Aged 18-65 years
- ASA physical status Ⅱ-Ⅲ
Who cannot join
- 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
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- 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
About this study
Official title: Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia
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.
Read the 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.
- Conditions
- Cervical Cancer, Metastatic Cancer
- Being tested
- Lidocaine, Normal saline (NS)
- Keywords
- Cervical cancer, Tumor progression, Lidocaine, Metalloproteinases, vascular endothelial growth factor, epidermal growth factor, thrombospondin2
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Metastasis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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.
Normal saline (NS)Other
Patients are received equal volumes of saline intravenously until the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
the severity of pain measured using Visual Analogue Score (VAS) on postoperative days at the moment, 12, 24 and 48 hours after surgery
Measured: at the end of operation and 48 hours after operation
Resumption of bowel function
Record the time to first flatus and the first defecation
Measured: at the end of operation and 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560035
- Sponsor's protocol ID
- maling20220922
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia
- ClinicalTrials.gov ID
- NCT05560035
- Acronym / sponsor ID
- maling20220922
- Conditions
- Cervical Cancer, Metastatic Cancer
- Keywords
- Cervical cancer, Tumor progression, Lidocaine, Metalloproteinases, vascular endothelial growth factor, epidermal growth factor, thrombospondin2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineIntravenous 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 | Other: Normal saline (NS)Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients were scheduled by following cervical cancer surgery under general anesthesia
- Aged 18-65 years
- ASA physical status Ⅱ-Ⅲ
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineIntravenous 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. | Drug | Lidocaine |
| Normal saline (NS)Patients are received equal volumes of saline intravenously until the end of the surgery | Other | Normal saline |
Primary outcome
Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively
Time frame: at the end of operation and 48 hours after operation
Resumption of bowel function
Time frame: at the end of operation and 48 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal saline (NS) in people with Cervical Cancer and Metastatic Cancer, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery (time frame: Baseline and 48 hours after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.