Perioperative Lignocaine and Sleep Disturbance

Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep

The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne in a multimodal analgesic protocol on the architecture sleep during the first postoperative night.

Study Overview

• Status: Unknown
• Conditions: Sleep Disturbance
• Intervention / Treatment: Drug: Lidocaïne 2%; Drug: Placebo (for Lidocaïne)

Detailed Description

To study the effect of lidocaïne, we plan to include 40 patients, randomized in 2 groups, undergoing open prostate surgery in this randomized placebo-controlled trial.

Before anesthesia induction, these patients receive an intravenous lidocaine infusion (bolus 1,5 mg.kg-1 followed by a continuous infusion of 2mg.kg-1.h during 24 hours) or an equal volume of placebo. Then the anesthesia is induced with propofol, sufentanil et rocuronium. The postoperative analgesia is provided by paracetamol, tramadol and patient-controlled analgesia (PCA) with morphine or oral oxycodone. A polysomnography is registred on the preoperative night and on the first postoperative night.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Radical prostatectomy

Exclusion Criteria:

• BMI > 30
• Neurologic/psychiatric diseases or therapeutics, seizyres
• Cardiac disease, second or third degree atrioventricular block
• Obstructive sleep apnea syndrome
• History of liver or renal insufficiency
• and any contraindication to the anesthetic protocol of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaïne 2%; Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h	Drug: Lidocaïne 2%; Continuous infusion during per and postoperative periods; Other Names: lignocaïne; Linisol
Placebo Comparator: Placebo (for Lidocaïne); Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h	Drug: Placebo (for Lidocaïne); Continuous infusion during per and postoperative periods; Other Names: NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep	Postoperaty day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep latence	Postoperaty day 1
Sleep time	Postoperaty day 1
Cumulative Opioid use	Postoperaty day 1
Quality of analgesia (Visual Analogic Scale)	Postoperaty day 1

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Isabelle Maquoi, CHU Liege - Department of Anesthesia and Intensive Care Medicine

Publications and helpful links

General Publications

• Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
• Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: ULiege

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No