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Lidocaine Infusion in Radical Cystectomy

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Postoperative Ileus

Treatments

Drug: IV normal saline
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03047057
SM12017

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

57 participants in 2 patient groups, including a placebo group

Lidocaine
Experimental group
Description:
IV Lidocaine infusion
Treatment:
Drug: Lidocaine
Control
Placebo Comparator group
Description:
IV normal saline infusion
Treatment:
Drug: IV normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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