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

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ClinicalTrials.gov Identifier: NCT03110120
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Analgesia Robotic Surgery Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline Drug: 0.5% levobupivacaine injectable solution with physiological saline Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
Study Start Date : May 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: serratus
Serratus plane block and local control
Drug: 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
Other Name: serratus plane block

Drug: 0.5% levobupivacaine injectable solution with physiological saline
local infiltration of the wound with 20 ml of injectable solution of physiological saline
Other Name: local control

Sham Comparator: local
serratus control and local anesthesia
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
Other Name: local anesthesia

Drug: 0.5% levobupivacaine injectable solution with physiological saline
Serratus plane block realized with 20 ml of injectable solution of physiological saline
Other Name: local serratus




Primary Outcome Measures :
  1. D0 pain intensity [ Time Frame: 1 day ]
    Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)


Secondary Outcome Measures :
  1. D1 pain intensity [ Time Frame: 3 days ]
    Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)

  2. morphine consumption [ Time Frame: 5 days ]
    Consumption of morphine the day and 4 days after surgery as recorded on the PCA.

  3. persistence of a chronic pain [ Time Frame: 3 months ]
    Phone call 3 month after surgery to evaluate the persistence of pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • non robot-assisted surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110120


Locations
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Belgium
Watremez Christine
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Christine Watremez, MD, PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03110120     History of Changes
Other Study ID Numbers: 2015/07JAN/008
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Levobupivacaine
Pharmaceutical Solutions
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents