Lidocaine Infusion in Radical Cystectomy

Postoperative Ileus Clinical Trial

Official title:

Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047057
• Other study ID #: SM12017
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• Lidocaine
IV Lidocaine infusion
• IV normal saline
IV normal saline infusion

Locations

Country	Name	City	State
Egypt	Seham Mohamed Moeen Ibrahim	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative return of gastrointestinal (GI) function	Time to the first defecation	15 day
Secondary	Postoperative Pain	a 10 cm visual analog pain scale (VAS) at rest and during mobilization	72 hours after surgery