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Ultrasound Guided Erector Spinae Plane Block in Breast 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: NCT03660020
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rasha Hamed, Assiut University

Study Description
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Brief Summary:
hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Local anesthetic Drug: Hyaluronidase Not Applicable

Detailed Description:
two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
Actual Study Start Date : May 19, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: local anaesthetic group Drug: Local anesthetic
ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only
Active Comparator: hyalorounidase group Drug: Hyaluronidase
hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy


Outcome Measures
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Primary Outcome Measures :
  1. degree of local anaesthetics spread after injection in both group [ Time Frame: 10 minutes after block ]
    spread of local anaesthics will be examined under floroscopic guide


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female
  2. ASA I, II, III
  3. Elective surgery

Exclusion Criteria:

  1. Patient refusal
  2. Infection at injection site
  3. Allergy to the given drugs
Contacts and Locations
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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): NCT03660020


Contacts
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Contact: rasha HAMED 088-01000440773 rashaahmed11@yahoo.com
Contact: saeid elsawy 088-01030072161 saeedelsawy17@gmail.com

Locations
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Egypt
Assiut university Recruiting
Assiut, Egypt, 71111
Contact: mohammed Ali Ahmed, MD       amira_salem2015@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: saeid elsawy Assiut University
More Information
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Responsible Party: Rasha Hamed, clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT03660020    
Other Study ID Numbers: NBBL
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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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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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Anesthetics
 Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents