Efficacy of Serratus Anterior Plane Block Mastectomy

NCT ID: NCT03944759

Last Updated: 2020-02-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2019-12-01

Brief Summary

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Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .

Detailed Description

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The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.

Patients and methods nclusion criteria:

-ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion criteria:

* Patient refusal
* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
* Allergy to the drugs used in the study
* Chronic pain therapy,
* BMI more than 30 kg/m2

Conditions

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Postoperative Pain Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GBM:( bupivacaine/magnesium sulphate)

serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.

GBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate

Group Type ACTIVE_COMPARATOR

serratus anterior plan block

Intervention Type PROCEDURE

serratus anterior plan block

GBN: ( bupivacaine/nalpuphin)

serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg.

Group Type ACTIVE_COMPARATOR

serratus anterior plan block

Intervention Type PROCEDURE

serratus anterior plan block

Interventions

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serratus anterior plan block

serratus anterior plan block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion Criteria

* -Patient refusal
* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
* Allergy to the drugs used in the study
* Chronic pain therapy,
* BMI more than 30 kg/m2
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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doaa rashwan

OTHER

Sponsor Role lead

Responsible Party

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doaa rashwan

Assistant profesor Doaa Rashwan

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Doaa Rashwan, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Beni-Suef University

Locations

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Faculty Of Medicine, Beni-Suef University

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMBSURECS/30042019/Ali

Identifier Type: -

Identifier Source: org_study_id

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