A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
This feasibility (small) study aims to see if it is possible to run a large study looking at the effect of lidocaine on large bowel cancer recurrence after surgery in the NHS hospitals.
详细描述
Strong preclinical evidence suggests that lidocaine, a type of local anaesthetic commonly used, could potentially reduce cancer recurrence if given during cancer surgery. This study will evaluate the feasibility of conducting a study comparing intravenous lidocaine infusion versus placebo administration for 24 hours from the start of general anaesthesia. The specific population will be any stage 2 or 3 colon or rectal cancer patient undergoing elective laparoscopic colorectal cancer surgery to look at postoperative cancer outcomes in two NHS settings. This study will explore the acceptability, facilitators and potential barriers of recruiting cancer patients, with possible anxieties of a new cancer diagnosis about to have major surgery along with other potential feasibility issues. It will also assess if follow-up and outcome data collection can be streamlined with usual care processes as much as possible and to guide the future definitive trial.
The project will:
- Perform a feasibility study. This will be similar in design to the future bigger study and will see:
- if there are any problems in giving lidocaine;
- if patients and clinicians would be happy to take part in a study using a design where some patients get the drug and others get a non-active substance (known as placebo);
- how many patients can we get from the different types and stages of bowel cancer;
- if patients can be followed up successfully;
- if we can collect all the data that we would need;
- what measures might work well for the future study;
- Look to see if blood tests can give some idea on how lidocaine might work in patients and if it can be confirmed in the bigger study.
The study will involve a small number of patients getting either lidocaine or placebo, and:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above, undergoing laparoscopic surgery with stage 2 or 3 colon cancer
- •Age 18 and above, undergoing laparoscopic surgery with stage 2 or 3 rectal cancer
- •Ability and willingness to consent
排除标准
- •Stage 1 and stage 4 colon or rectal cancer
- •Palliative surgery with no curative intent
- •Extensive comorbidities, i.e. American Society of Anesthesiologists (ASA) Score IV
- •Patients with known or suspected allergy to lidocaine
- •Patients who are currently pregnant* or breastfeeding
- •Patients who are likely to have adverse effects from the accumulation of intravenous lidocaine:
- •current liver disease with a liver function outside the normal laboratory range
- •current renal failure (eGFR <30)
- •cardiac conduction abnormalities based on history and confirmed by electrocardiogram
研究组 & 干预措施
lidocaine
An intravenous bolus of 2% lidocaine will be administered following the induction of anaesthesia at 1.5mg/kg ideal body weight over 20 minutes followed by intravenous infusion of 1.5 mg/kg/hour ideal body weight with a maximum rate of 120mg/hour for 24 hours.
干预措施: Lidocaine hydrochloride 2% for injection (Drug)
0.9% sterile Sodium Chloride solution for injection
An equivalent infusion rate (ml) of placebo will be administered following the induction of anaesthesia over 20 minutes followed by hourly equivalent intravenous infusion in ml/hr of placebo with a maximum rate of 6mls/hr (equivalent of 120mg/hour for lidocaine) for 24 hours.
干预措施: 0.9% sterile Sodium Chloride solution for injection (Drug)
结局指标
主要结局
Feasibility of recruitment
时间窗: Baseline
The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3.
Trial retention
时间窗: 12 months post randomisation
The number of participants who consent to participate who remain in the study until the end of follow up at 12 months.
Clinicians' reasons for not recruiting patients.
时间窗: Screening
Clinicians will be asked their reasons for not recruiting patients
The completion of data collection instruments
时间窗: 12 months post randomisation
on eCRF
Participant's feedback of study experiences
时间窗: Day 3 hospital stay
10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement.
Clinical staff feedback of study experiences
时间窗: Day 3 hospital stay
10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement.
Patients' reasons to refuse consent.
时间窗: Baseline
Patients who refuse consent will be asked for their reasons at the point of recruitment only
次要结局
- Disease-free survival(12-months post randomisation)
- Completion of EQ-5D-5L(12-months post randomisation)
- Completion of healthcare and social care resource use questionnaires(12-months post randomisation)
- Total hospital stays including readmission(12-months post randomisation)
- Completion of the cancer-specific quality of life questionnaires(12-months post randomisation)