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

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04429893

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Breast Chronic Pain Syndrome	Drug: magnesium sulphate Drug: bupivicaine	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: magnesium sulphate assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy Drug: bupivicaine assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
Active Comparator: Group B The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml	Drug: bupivicaine assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

Arm

Intervention/Treatment

Experimental: 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.

Drug: magnesium sulphate

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

Drug: bupivicaine

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

Active Comparator: Group B

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

Drug: bupivicaine

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

Outcome Measures

Primary Outcome Measures

assessment of the pain intensity [24 hours]
Pain assessment by visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehab Abd Elraof Abd Elaziz	Alexandria	Smouha	Egypt	000000

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Rehab A. Abd Elaziz, Ass.Prof., Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

rehab zayed, Assisstant Professor of Anesthesia, Alexandria University

ClinicalTrials.gov Identifier:

NCT04429893

Other Study ID Numbers:

0304543

First Posted:

Jun 12, 2020

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by rehab zayed, Assisstant Professor of Anesthesia, Alexandria University

serratus anterior plane block

magnesium sulphate

Additional relevant MeSH terms:

Chronic Pain

Magnesium Sulfate

Bupivacaine

Study Results

No Results Posted as of Aug 2, 2022