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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT03110120
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
25
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
  • Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
  • Drug: 0.5% levobupivacaine injectable solution with physiological saline
  • Drug: 0.5% levobupivacaine injectable solution with physiological saline
 N/A

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.

Study Design

Study Type:
Interventional
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 surgeryCompare 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 1, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • local serratus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. D0 pain intensity [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 [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 [5 days]

      Consumption of morphine the day and 4 days after surgery as recorded on the PCA.

    3. persistence of a chronic pain [3 months]

      Phone call 3 month after surgery to evaluate the persistence of pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery
    Exclusion Criteria:
    • non robot-assisted surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Watremez Christine Bruxelles Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    • Principal Investigator: Christine Watremez, MD, PhD, Cliniques universitaires Saint-Luc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT03110120
    Other Study ID Numbers:
    • 2015/07JAN/008
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Oct 10, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Agnosia
    Levobupivacaine
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Oct 10, 2017