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Lidocaine Infusion in Radical Cystectomy

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03047057
Collaborator
(none)
57
Enrollment
1
Location
2
Arms
16.6
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy
Actual Study Start Date :
Mar 3, 2017
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine

IV Lidocaine infusion

Drug: Lidocaine
IV Lidocaine infusion
Placebo Comparator: Control

IV normal saline infusion

Drug: IV normal saline
IV normal saline infusion
Other Names:
  • normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative return of gastrointestinal (GI) function [15 day]

      Time to the first defecation

    Secondary Outcome Measures

    1. Postoperative Pain [72 hours after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seham Mohamed Moeen Ibrahim Asyut Egypt 71111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seham Mohamed Moeen Ibrahim, lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03047057
    Other Study ID Numbers:
    • SM12017
    First Posted:
    Feb 8, 2017
    Last Update Posted:
    Aug 7, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Aug 7, 2018