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Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

NCT ID: NCT03110120

Last Updated: 2017-10-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

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The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

Detailed Description

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In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.

Conditions

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Analgesia Robotic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The patient where randomized by the investigator after inform consent was signed The investigator prepared the syringes named "serratus" and "local" with levobupivacaine 0.25 or saline according to randomization The care provider injected the prepared syringes respectively in the serratus plane or locally without knowing their contents The outcome assessor evaluated the post operative pain and the 3 months followup without knowing the randomization

Study Groups

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serratus

Serratus plane block and local control

Group Type ACTIVE_COMPARATOR

0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Intervention Type DRUG

Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

0.5% levobupivacaine injectable solution with physiological saline

Intervention Type DRUG

local infiltration of the wound with 20 ml of injectable solution of physiological saline

local

serratus control and local anesthesia

Group Type SHAM_COMPARATOR

0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Intervention Type DRUG

local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

0.5% levobupivacaine injectable solution with physiological saline

Intervention Type DRUG

Serratus plane block realized with 20 ml of injectable solution of physiological saline

Interventions

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0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Intervention Type DRUG

0.5% levobupivacaine injectable solution with 10 ml of physiological saline

local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Intervention Type DRUG

0.5% levobupivacaine injectable solution with physiological saline

Serratus plane block realized with 20 ml of injectable solution of physiological saline

Intervention Type DRUG

0.5% levobupivacaine injectable solution with physiological saline

local infiltration of the wound with 20 ml of injectable solution of physiological saline

Intervention Type DRUG

Other Intervention Names

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serratus plane block local anesthesia local serratus local control

Eligibility Criteria

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Inclusion Criteria

* mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery

Exclusion Criteria

* non robot-assisted surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Watremez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Watremez Christine

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2015/07JAN/008

Identifier Type: -

Identifier Source: org_study_id