Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome (FLICOR)

Imperial College London

Status: Enrolling

Conditions: Recurrent Cancer; Quality of Life; Colorectal Cancer

Treatments: Drug: 0.9% sterile Sodium Chloride solution for injection; Drug: Lidocaine hydrochloride 2% for injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05250791

NIHR301741 (Other Grant/Funding Number)

21CX7298

1004491 (Registry Identifier)

2021-006185-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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:

1. 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;

2. 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:

• filling in questionnaires to measure quality of life;
• follow up phone call at 6 and 12 months after surgery;
• having their records looked at to see if cancer comes back;
• both patients and clinicians to fill in a feedback questionnaire to see how they get on with the study processes;
• having extra blood tests before and after they finish the lidocaine/placebo infusion.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)
  • epilepsy
  • cardiac conduction abnormalities based on history and confirmed by electrocardiogram

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups, including a placebo group

lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine hydrochloride 2% for injection

0.9% sterile Sodium Chloride solution for injection

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% sterile Sodium Chloride solution for injection