Intravenous Lidocaine for Cystectomy Procedures

NCT02924480 | Completed

• 1 other identifier: 16-247
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be enrolled into a randomized, double blinded clinical trial to assess if postoperative pain and ileus are reduced by perioperative intravenous lidocaine infusion versus placebo. The hypothesis is that patients receiving the lidocaine infusion will experience better pain control and ileus resolution. It is believed that lidocaine patients will also have less opioid requirement, less mortality, a shorter length of stay, less nausea /vomiting, and fewer adverse events.

Conditions

Invasive Bladder Cancer

Keywords

invasive bladder cancer; cystectomy; high grade bladder cancer

Outcome Measures

Primary Outcomes (2)

• Reduced pain post-operatively using verbal analog score

  Use verbal analog score to assess patients pain and compare between study and control groups. This will determine if patients in the lidocaine study arm experience less pain than those in the placebo group.

  108 hours after surgery

• Time until Ileus resolution

  Time to ileus resolution will be compared between study and control groups using the end of surgery time to the time of first bowl movement. This should determine if those in the lidocaine study arm experience quicker Ileus resolution compared to those in the placebo study arm.

  108 hours after surgery

Secondary Outcomes (1)

• Pain management during the first 24 hours after surgery using the American Pain Society Patient Outcome Questionnaire (APS-POQ-R)

  24 hours post-operatively

Study Arms (2)

Lidocaine Study Group

ACTIVE COMPARATOR

Intravenous Lidocaine for Cystectomy Procedures: During the surgery, the lidocaine infusion group will receive the lidocaine bolus (1.5mg/kg bolus followed by a 2mg/kg/h infusion) 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.

Procedure: Cystectomy; Drug: Lidocaine

Placebo Study Group

PLACEBO COMPARATOR

Intravenous Saline for Cystectomy Procedures: During the surgery, patients will be randomized to the control group and receive a normal saline bolus 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.

Procedure: Cystectomy; Drug: Saline

Interventions

Cystectomy PROCEDURE

Lidocaine Study Group; Placebo Study Group

Lidocaine DRUG

Patients will receive lidocaine infusion during surgery

Lidocaine Study Group

Saline DRUG

Patients will receive saline infusion during surgery

Placebo Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing a cystectomy with an American Society of Anesthesiologists physical status classification (ASA) of 1 or 2.

You may not qualify if:

• Any patients with a history of substance abuse, allergy to amides, and current treatment with antiarrhythmic medications (due to lidocaine being a class 1b antiarrhythmic agent) will be excluded.
• Patients will also be excluded if they are pregnant or have a history of chronic pain syndrome, chronic bowel or liver dysfunction.
• Patients with chronic opioid use, and therefore opioid tolerance, and history of opioid addiction will also be excluded due to likely increased opioid needs for equivalent pain control.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Urology center of charleston

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Interventions

Cystectomy; Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Samuel G Deem, DO

  CAMC Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Surgeon

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: October 12, 2016
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

US (1)