Perioperative Lignocaine and Sleep Disturbance

Phase 4

• Conditions: Sleep Disturbance
• Interventions: Drug: Lidocaïne 2%; Drug: Placebo (for Lidocaïne)

• Registration Number: NCT03317912
• Lead Sponsor: University of Liege

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-03-31
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-17
• Last Update Submitted: 2017-10-17
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-23
• Study Start: 2017-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaïne 2%	Lidocaïne 2%	Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
Placebo (for Lidocaïne)	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

Primary Outcome Measures

Name	Time	Method
Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep	Postoperaty day 1

Secondary Outcome Measures

Name	Time	Method
Cumulative Opioid use	Postoperaty day 1
Sleep latence	Postoperaty day 1
Sleep time	Postoperaty day 1
Quality of analgesia (Visual Analogic Scale)	Postoperaty day 1