Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Erector Spinae Plane Block in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997019
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rasha Hamed, Assiut University

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
pain score [ Time Frame: 48 hours ]
NRS will be used to assess pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
  • anaesthesia consumption [ Time Frame: 6 hours ]
    cumulative anaesthesia MAC
  • ultrasound guided postoperative diaphragmatic excursion [ Time Frame: 24 hours ]
    diaphragmatic movement during inspiration an expiration
  • spirometric respiratory funtion [ Time Frame: 24 hours ]
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 Erector Spinae Plane Block in Cardiac Surgery
Official Title  ICMJE Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
Brief Summary ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
group A WILL RECEIVE OPOID analgesia group B will receive ESP block
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
both patient and data collector will be unaware of the group nature
Primary Purpose: Prevention
Condition  ICMJE Pain, Acute
Intervention  ICMJE
  • Procedure: opioid analgesia
    opioid analgesia will be used with general anaesthesia
  • Procedure: ESP block
    ultrasound guided ESP Block before anaesthesia induction
Study Arms  ICMJE
  • Active Comparator: group A
    opioid analgesia
    Intervention: Procedure: opioid analgesia
  • Active Comparator: group B
    ESP block
    Intervention: Procedure: ESP block
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • elective surgery

Exclusion Criteria:

  • emergency
  • patient refusal
  • infection at or near catheter insertion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997019
Other Study ID Numbers  ICMJE FXLD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rasha Hamed, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date June 2019

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