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Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Local anesthetic
Hyaluronidase
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

local anaesthetic group

hyalorounidase group

Arm Description

Outcomes

Primary Outcome Measures

degree of local anaesthetics spread after injection in both group
spread of local anaesthics will be examined under floroscopic guide

Secondary Outcome Measures

Full Information

First Posted
July 20, 2018
Last Updated
April 7, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03660020
Brief Title
Ultrasound Guided Erector Spinae Plane Block in Breast Surgery
Official Title
Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 19, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local anaesthetic group
Arm Type
Sham Comparator
Arm Title
hyalorounidase group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Local anesthetic
Intervention Description
ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only
Intervention Type
Drug
Intervention Name(s)
Hyaluronidase
Intervention Description
hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy
Primary Outcome Measure Information:
Title
degree of local anaesthetics spread after injection in both group
Description
spread of local anaesthics will be examined under floroscopic guide
Time Frame
10 minutes after block

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female ASA I, II, III Elective surgery Exclusion Criteria: Patient refusal Infection at injection site Allergy to the given drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rasha HAMED
Phone
088-01000440773
Email
rashaahmed11@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
saeid elsawy
Phone
088-01030072161
Email
saeedelsawy17@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
saeid elsawy
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohammed Ali Ahmed, MD
Email
amira_salem2015@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

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