Lidocaine Infusion in Radical Cystectomy
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
Laatst geverifieerd: | 07/31/2018 |
Eerste ingediend: | 02/05/2017 |
Geschatte inschrijving ingediend: | 02/05/2017 |
Eerst geplaatst: | 02/07/2017 |
Laatste update ingediend: | 08/05/2018 |
Laatste update geplaatst: | 08/06/2018 |
Werkelijke startdatum van het onderzoek: | 03/02/2017 |
Geschatte primaire voltooiingsdatum: | 07/19/2018 |
Geschatte voltooiingsdatum van het onderzoek: | 07/19/2018 |
Conditie of ziekte
Interventie / behandeling
Drug: Lidocaine
Drug: Control
Fase
Armgroepen
Arm | Interventie / behandeling |
---|---|
Experimental: Lidocaine IV Lidocaine infusion | Drug: Lidocaine IV Lidocaine infusion |
Placebo Comparator: Control IV normal saline infusion | Drug: Control IV normal saline infusion |
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie | 45 Years Naar 45 Years |
Geslachten die in aanmerking komen voor studie | All |
Accepteert gezonde vrijwilligers | Ja |
Criteria | 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 |
Resultaat
Primaire uitkomstmaten
1. Postoperative return of gastrointestinal (GI) function [15 day]
Secundaire uitkomstmaten
1. Postoperative Pain [72 hours after surgery]