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Perioperative Lignocaine and Sleep Disturbance

NCT ID: NCT03317912

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaïne 2%

Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h

Group Type ACTIVE_COMPARATOR

Lidocaïne 2%

Intervention Type DRUG

Continuous infusion during per and postoperative periods

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

Group Type PLACEBO_COMPARATOR

Placebo (for Lidocaïne)

Intervention Type DRUG

Continuous infusion during per and postoperative periods

Interventions

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Lidocaïne 2%

Continuous infusion during per and postoperative periods

Intervention Type DRUG

Placebo (for Lidocaïne)

Continuous infusion during per and postoperative periods

Intervention Type DRUG

Other Intervention Names

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lignocaïne Linisol NaCl 0.9%

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Maquoi

Role: PRINCIPAL_INVESTIGATOR

CHU Liege - Department of Anesthesia and Intensive Care Medicine

Central Contacts

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Isabelle Maquoi

Role: CONTACT

Phone: 32 4 366 7179

Email: [email protected]

Gregory Hans

Role: CONTACT

Phone: 32 4 366 7179

References

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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.

Reference Type RESULT
PMID: 17197840 (View on PubMed)

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.

Reference Type RESULT
PMID: 24634631 (View on PubMed)

Other Identifiers

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ULiege

Identifier Type: -

Identifier Source: org_study_id