Using intravenous lidocaine during colorectal surgery to improve pain management and immune function
Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study
This study is testing whether giving lidocaine through an IV during colorectal surgery can help reduce pain and improve recovery and immune function compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT03410836 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of intravenous lidocaine (IVL) administered during laparoscopic colorectal surgery on pain management and immune function. The hypothesis is that IVL will reduce the need for remifentanil, improve recovery times, and enhance immune responses post-surgery. The study will compare outcomes between patients receiving IVL and those receiving a placebo, focusing on pain scores, opioid consumption, and immune cell activity for 48 hours after surgery. The goal is to determine if IVL can improve postoperative recovery and immune health in colorectal surgery patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing elective laparoscopic colorectal surgery with ASA status I, II, or III.
Not a fit: Patients with arrhythmias, those on immunosuppressive treatments, or those unable to use postoperative pain management methods may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain management and improved immune function for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown promising results with intravenous lidocaine in abdominal surgeries, but this specific application in colorectal surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA status I, II or III * Patients older than 18 years * Colonic surgery * Classical management of ERAS program patients in our center Exclusion Criteria: * Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy * Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours * conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique * Pregnant women * Inability to complete the questions related to this study * Inability to use hydromorphone postoperative PCA * Intolerance or allergy to lidocaine, hydromorphone or any other drug that is included in the protocol for perioperative management Unexpected events leading to the exclusion: * Difficult unplanned intubation * Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)
Where this trial is running
Montréal, Quebec
- Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Philippe Richebé, MD, PhD — CIUSSS Est de l'ile de Montreal
- Study coordinator: Philippe Richebé, MD PhD
- Email: philippe.richebe@umontreal.ca
- Phone: 514-743-6558
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.