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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

Brief Summary:
ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery

Condition or disease Intervention/treatment Phase
Pain, Acute Procedure: opioid analgesia Procedure: ESP block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: group A
opioid analgesia
Procedure: opioid analgesia
opioid analgesia will be used with general anaesthesia

Active Comparator: group B
ESP block
Procedure: ESP block
ultrasound guided ESP Block before anaesthesia induction




Primary Outcome Measures :
  1. pain score [ Time Frame: 48 hours ]
    NRS will be used to assess pain


Secondary Outcome Measures :
  1. anaesthesia consumption [ Time Frame: 6 hours ]
    cumulative anaesthesia MAC

  2. ultrasound guided postoperative diaphragmatic excursion [ Time Frame: 24 hours ]
    diaphragmatic movement during inspiration an expiration

  3. spirometric respiratory funtion [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective surgery

Exclusion Criteria:

  • emergency
  • patient refusal
  • infection at or near catheter insertion

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): NCT03997019


Locations
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Egypt
Faculty of Medicine Recruiting
Asyut, Egypt, 71111
Contact: rasha hamed    01000440773    rashaahmed11@yahoo.com   
Contact: saeed elsawy    01030072161    saeedelsawy17@gmail.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: Rasha Hamed, lecturer of anaesthesia and pain management, Assiut University
ClinicalTrials.gov Identifier: NCT03997019    
Other Study ID Numbers: FXLD
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents