Clinical trial

A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery

Name

21CX7298

Description

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.

Trial arms

Trial start

2023-02-02

Estimated PCD

2024-09-15

Trial end

2024-09-15

Status

Recruiting

Treatment

Lidocaine hydrochloride 2% for injection

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.

Arms:

lidocaine

Other names:

Xylocaine

0.9% sterile Sodium Chloride solution for injection

Administered as lidocaine

Arms:

0.9% sterile Sodium Chloride solution for injection

Other names:

Saline

Size

Primary endpoint

Feasibility of recruitment

Baseline

Trial retention

12 months post randomisation

The completion of data collection instruments

6 months post randomisation

The completion of data collection instruments

12 months post randomisation

Participant's feedback of study experiences

Day 3 hospital stay

Clinical staff feedback of study experiences

Day 3 hospital stay

Patients' reasons to refuse consent.

Baseline

Clinicians' reasons for not recruiting patients.

Screening

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-06-09

1 organization

2 products

3 indications

Organization

Imperial College London

Product

Lidocaine hydrochloride

Indication

Indication

Indication

Product