Lidocaine Infusion in Radical Cystectomy
- Registration Number
- NCT03047057
- Lead Sponsor
- Assiut University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 45-75 yr ASA class I,II, and III Elective radical cystectomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control IV normal saline IV normal saline infusion Lidocaine Lidocaine IV Lidocaine infusion
- Primary Outcome Measures
Name Time Method Postoperative return of gastrointestinal (GI) function 15 day Time to the first defecation
- Secondary Outcome Measures
Name Time Method Postoperative Pain 72 hours after surgery a 10 cm visual analog pain scale (VAS) at rest and during mobilization
Trial Locations
- Locations (1)
Seham Mohamed Moeen Ibrahim
🇪🇬Asyut, Egypt
Seham Mohamed Moeen Ibrahim🇪🇬Asyut, Egypt