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Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

NCT ID: NCT04239716

Last Updated: 2023-11-30

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

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-31

Brief Summary

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local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Detailed Description

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inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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regional anesthesia

combination of erector spinae plane block (ESPB) and interscalene block(IB).the ESPB will be performed using linear ultrasound transducer (Philips® cx 50 extreme edition, USA) and we will inject 20 ml solution(10 ml 0.5% bupivacaine, 5 ml 2% lidocaine, and 5 ml normal saline). the IB will be performed using the same ultrasound machine and injecting the same solution

Group Type EXPERIMENTAL

regional anesthesia

Intervention Type OTHER

combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection

Interventions

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regional anesthesia

combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patients aged 40-85 years old
* American Society of Anesthesiologists' physical status III and IV
* Planned for modified radical mastectomy with axillary lymph node dissection

Exclusion Criteria

* Patient refusal
* Neurological or psychiatric disorders
* Local infection at injection site
* Spine or chest wall deformity
* Allergy or any contraindication to any of the study drugs
* Opioid or alcoholic addiction
* Chronic pain of any cause
* Uncooperative patients.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Mohamed Elsayed Afandy

UNKNOWN

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mona Raafat Elghamry

Dr. Mona Raafat Elghamry Assistant Professor of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona R Elghamry, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University, Faculty of Medicine

Mohamed E Afandy, MD

Role: STUDY_DIRECTOR

Tanta University, Faculty of Medicine

Locations

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Tanta University, Faculty of Medicine

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mastectomy regional anesthesia

Identifier Type: -

Identifier Source: org_study_id