Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

NCT ID: NCT03660020

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-19

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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local anaesthetic group

Group Type SHAM_COMPARATOR

Local anesthetic

Intervention Type DRUG

ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only

hyalorounidase group

Group Type ACTIVE_COMPARATOR

Hyaluronidase

Intervention Type DRUG

hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy

Interventions

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Local anesthetic

ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only

Intervention Type DRUG

Hyaluronidase

hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Hamed

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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saeid elsawy

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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rasha HAMED

Role: CONTACT

088-01000440773

saeid elsawy

Role: CONTACT

088-01030072161

Facility Contacts

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mohammed Ali Ahmed, MD

Role: primary

Other Identifiers

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NBBL

Identifier Type: -

Identifier Source: org_study_id

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