Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery

Study Overview
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Brief Summary
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Lidocaine is an amide local anaesthetic and an antiarrhythmic agent, first synthesized in 1942, and after approval for human use was launched in 1948 in Sweden The first observations of post operative analgesic effects of perioperative intravenous lidocaine (IVL) were initially proposed in 1951 subsequently many more enthusiastic reports followed. Postoperative formal clinical evaluations in the perioperative setting were conducted in the late 1950s where IV Lidocaine was demonstrated to have a postoperative analgesic effect without posing the risk of respiratory depression, reducing the occurrence of postoperative nausea and vomiting (PONV), and enhance post-surgical recovery. IV Lidocaine also potentiated the depth of anesthesia and led to a better tolerance of endotracheal intubation.Around 40% of patients experience a delay in resumption of normal bowel function after colorectal surgery. This delay leads to symptoms of nausea, vomiting, constipation, and abdominal distension, which then require unpleasant supportive interventions such as intravenous fluids and nasogastric tube insertion. There is no remedy to address this delay. ALLEGRO, A placebo-controlled randomized trial of intravenous Lidocainein accelerating Gastrointestinal Recovery surgery, is the latest ongoing multicenter research study across the United Kingdom, investigating the use of intravenous lidocaine to improve recovery after colorectal surgery

Official Title
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Effect of Intraoperative Lidocaine Infusion on Inducing Intestinal Motility and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery. A Prospective, Comparative, Randomized Double Blind Controlled Clinical Study

Conditions
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Enhanced Recovery After Surgery

Intervention / Treatment
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* Drug: normal saline group
* Drug: lidocaine group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older. Both sexes, males and females Patients scheduled for elective intestinal surgery. Body mass index (BMI) 18-30 kg•m-2. ASA I - II. Exclusion Criteria: Patient refusal Patients with preoperative gastrointestinal dysfunction. Patients with a history of drug abuse, or long-term opioid use. ASA III and VI Patients with a history of previous gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br> | Drug: normal saline group<br>* normal saline infusion at the start of surgery<br>|
| Active Comparator: lidocaine group<br> | Drug: lidocaine group<br>* lidocaine infusion at the start of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative visual analogue score (VAS SCORE) | assessment of postoperative pain will be carried by VAS in which zero=no pain and 10= worst pain ever | 24 hour |