Clinical trial · Interventional
Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome
A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery
NCT05250791CI-TRIAL-00067042FLICORunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Quality of Life | — | UNRESOLVED | — |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% sterile Sodium Chloride solution for injection | Drug | — | UNRESOLVED |
| Lidocaine hydrochloride 2% for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- lidocaine
- 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.
- interventionNames
- Drug: Lidocaine hydrochloride 2% for injection
- type
- PLACEBO_COMPARATOR
- label
- 0.9% sterile Sodium Chloride solution for injection
- 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.
- interventionNames
- Drug: 0.9% sterile Sodium Chloride solution for injection
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWest R, Soo CP, Murphy J, Vizcaychipi MP, Ma D. A protocol for a pilot study to assess the feasibility of a randomised clinical trial of perioperative intravenous lidocaine on colorectal cancer outcome after surgery (FLICOR trial). BJA Open. 2023 Jun;6:100138. doi: 10.1016/j.bjao.2023.100138. PMID 37387798