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

Alexandria University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Chronic Pain Syndrome; Cancer Breast

Treatments: Drug: magnesium sulphate; Drug: bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04429893

0304543

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group BM

Experimental group

Description:

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.

Treatment:

Drug: bupivicaine

Drug: magnesium sulphate

Group B

Active Comparator group

Description:

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

Treatment:

Drug: bupivicaine