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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

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date October 10, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03110120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • 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)
  • morphine consumption [ Time Frame: 5 days ]
    Consumption of morphine the day and 4 days after surgery as recorded on the PCA.
  • persistence of a chronic pain [ Time Frame: 3 months ]
    Phone call 3 month after surgery to evaluate the persistence of pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery
Official Title  ICMJE Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Analgesia
  • Robotic Surgery
Intervention  ICMJE
  • 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 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
  • 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
Study Arms  ICMJE
  • Active Comparator: serratus
    Serratus plane block and local control
    Interventions:
    • Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
    • Drug: 0.5% levobupivacaine injectable solution with physiological saline
  • Sham Comparator: local
    serratus control and local anesthesia
    Interventions:
    • Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
    • Drug: 0.5% levobupivacaine injectable solution with physiological saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • non robot-assisted surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03110120
Other Study ID Numbers  ICMJE 2015/07JAN/008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine Watremez, MD, PhD Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP