Using lidocaine infusion during bowel cancer surgery to improve outcomes
A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery
NA · Imperial College London · NCT05250791
This study is testing if giving lidocaine through an IV during bowel cancer surgery can help reduce the chance of cancer coming back for patients with stage 2 or 3 colorectal cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT05250791 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the possibility of conducting a larger trial that investigates the effects of intravenous lidocaine infusion on cancer recurrence in patients undergoing elective laparoscopic surgery for stage 2 or 3 colorectal cancer. The study will compare lidocaine administration to a placebo over a 24-hour period starting from general anesthesia. It will assess the acceptability of the study design among patients and clinicians, identify potential recruitment barriers, and streamline follow-up and data collection processes. The findings will inform the design of a future definitive trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with stage 2 or 3 colon or rectal cancer scheduled for laparoscopic surgery.
Not a fit: Patients with stage 1 or stage 4 cancer, those undergoing palliative surgery, or individuals with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cancer outcomes and quality of life for patients undergoing bowel cancer surgery.
How similar studies have performed: While there is strong preclinical evidence supporting the use of lidocaine in this context, this specific approach is novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London and 1 other locations
- Chelsea and Westminster Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: West Raha, MBChB — Imperial College London
- Study coordinator: West Raha, MBChB
- Email: flicor.trial@imperial.ac.uk
- Phone: 07496833117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Quality of Life, Recurrent Cancer, Perioperative, Intravenous lidocaine, cancer recurrence, colorectal cancer, quality of life