Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy

NCT ID: NCT04429893

Last Updated: 2022-08-02

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

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-30

Brief Summary

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Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

Detailed Description

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Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Conditions

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Cancer Breast Chronic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group BM

The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Group Type EXPERIMENTAL

magnesium sulphate

Intervention Type DRUG

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

bupivicaine

Intervention Type DRUG

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

Group B

The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml

Group Type ACTIVE_COMPARATOR

bupivicaine

Intervention Type DRUG

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

Interventions

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magnesium sulphate

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

Intervention Type DRUG

bupivicaine

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult female patients
* American Society Of Anesthesiologists (ASA) class I or II
* scheduled for elective unilateral modified radical mastectomy

Exclusion Criteria

* patient refusal
* bilateral breast surgery
* coagulation disorders
* body mass index\> 35
* allergy to local anaesthetics or magnesium sulphate
* severe respiratory or cardiac disorders
* pre-existing neurological deficits
* liver or renal insufficiency
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Rehab Abd Elraof Abd Elaziz

Alexandria, Smouha, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: CONTACT

01001073703 ext. 020

Facility Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: primary

01001073703 ext. 020

Other Identifiers

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0304543

Identifier Type: -

Identifier Source: org_study_id

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