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

Phase 2

• Conditions: Chronic Pain Syndrome; Cancer Breast
• Interventions: Drug: bupivicaine; Drug: magnesium sulphate

• Registration Number: NCT04429893
• Lead Sponsor: Alexandria University

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.

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 Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2022-01-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	bupivicaine	The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml
Group BM	bupivicaine	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 BM	magnesium sulphate	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.

Primary Outcome Measures

Name	Time	Method
assessment of the pain intensity	24 hours	Pain assessment by visual analogue scale

Trial Locations

Locations (1)

Rehab Abd Elraof Abd Elaziz; 🇪🇬 Alexandria, Smouha, Egypt