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OpenTrials
Completed

NCT Number: NCT03047057

Lidocaine Infusion in Radical Cystectomy

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.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seham Mohamed Moeen Ibrahim

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

IV Lidocaine infusion

IV normal saline

Drug

IV normal saline infusion

Other names: normal saline

Primary outcomes

  1. Postoperative return of gastrointestinal (GI) function

    Time frame: 15 day

    Time to the first defecation

Secondary outcomes

  1. Postoperative Pain

    Time frame: 72 hours after surgery

    a 10 cm visual analog pain scale (VAS) at rest and during mobilization

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2017
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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