Lidocaine Infusion in Radical Cystectomy

Study Overview
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Brief Summary
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Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.

Detailed Description
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Radical cystectomy remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. The high rates of morbidity and mortality reflect the fact that the majority of patients undergoing this procedure are elderly patients with multiple comorbidities. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy. To reduce the risk of ileus, prokinetics such as metoclopramide should be used postoperatively. Local anesthetics exert their actions as local anesthesia and antiarrhythmic through Na channels blocking but still have many other important actions through other receptors (e.g., m1 muscarinic receptors) that occur at very low plasma levels compared to levels needed for Na channels blocking, one of these actions is the anti-inflammatory effect against surgical stress response. Several randomized studies found that i.v. lidocaine shortens duration of postoperative ileus and some of it reported decreased postoperative pain with i.v. lidocaine, so they recommended i.v. lidocaine as a safe, simple, and less invasive method for management of postoperative ileus and equal to postoperative epidural analgesia.

Official Title
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Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: Lidocaine
* Drug: IV normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-75 yr ASA class I,II, and III Elective radical cystectomy Exclusion Criteria: Allergy to the study medication, pre-existing chronic pain at any site requiring treatment, Psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>IV Lidocaine infusion | Drug: Lidocaine<br>* IV Lidocaine infusion<br>|
| Placebo Comparator: Control<br>IV normal saline infusion | Drug: IV normal saline<br>* IV normal saline infusion<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative return of gastrointestinal (GI) function | Time to the first defecation | 15 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | a 10 cm visual analog pain scale (VAS) at rest and during mobilization | 72 hours after surgery |