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Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

Phase 3
18 Years
75 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

One of the purposes of postoperative care is to shorten the duration of recovery, in order
to reduce the complications and to improve the quality of life. After abdominal surgery, two
factors can be modified: early mobilisation, thanks to optimal pain control, and return to a
normal feeding, permitted by transit recovery. Opioids, which are usually used for pain
control, delay the intestinal transit and can be responsible for side effects like
drowsiness, nausea, urine retention.

Lidocaine is a local anaesthetic, which means that it can stop the pain if it is
administrated around the nerves. It can also be used intravenously. In this way, it is
supposed to decrease opioid consumption, accelerate intestinal transit and even decrease
inflammation. Side effects of lidocaine appear at higher plasma concentrations than those
considered in the study.

After randomisation, the patient will receive either intravenous lidocaine during the
surgery and 24 hours after the surgery, or physiological serum (like placebo). Every patient
will dispose of patient-controlled-analgesia with morphine and of a standardised care
management. Data will be collected concerning pain level, morphine consumption, psychomotor
performances, duration of ileus, speed of activity recovery, quality of recovery, and side
effects. Biological evaluation of lidocaine concentration and inflammation will also be

Inclusion Criteria:

- Colorectal neoplasm

- Radical surgery

- Median incision

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) score equal to or up to 3

- Unwilling or unable to use patient-controlled analgesia (PCA)

- Chronic consumption of opioids

- Chronic drug or alcohol abuse

- Chronic pain

- Unable to read or write text

- Inflammatory disease of intestinal tract

- Allergy to morphine

- Allergy to lidocaine

- Severe atrioventricular conduction dysfunction without stimulator

- Porphyry

- Uncontrolled epilepsy

- History of malign hyperthermia

- Severe cardiac failure

- Hepatic failure

- Myasthenia

- Treatment with beta blockers, antiarrhythmic calcium blockers, sultopride,
nonselective monoamine oxidase inhibitor (MAOI)

- Locoregional anaesthesia planned

- Associated surgery concerning liver, pancreas, or gall bladder

- Laparoscopic surgery

- Severe psychiatric pathology

- Refusal of the patient

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Readiness for discharge, checked twice a day

Safety Issue:


Principal Investigator

Claude Jolly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

May 2005

Completion Date:

May 2007

Related Keywords:

  • Colorectal Neoplasms
  • Double blind method
  • Prospective study
  • Lidocaine/administration and dosage/therapeutic use
  • Anaesthetics local/administration and dosage
  • Opioids/administration and dosage
  • Pain, postoperative
  • Perioperative care
  • Postoperative care
  • Analgesia, Patient-controlled
  • Length of stay
  • Survival analysis
  • Patient satisfaction
  • Surgery
  • Middle age
  • Adult
  • Aged
  • Neoplasms
  • Colorectal Neoplasms