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

Chronic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429893
• Other study ID #: 0304543
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: September 2022

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: Rehab A. Abd Elaziz, Ass. Prof.
• Phone: 01001073703
• Email: trcium2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Breast
• Chronic Pain
• Chronic Pain Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Rehab Abd Elraof Abd Elaziz	Alexandria	Smouha

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the pain intensity	Pain assessment by visual analogue scale	24 hours