Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

South Egypt Cancer Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pain, Postoperative

Treatments: Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy; Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy; Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04732364

peter SECI

Details and patient eligibility

About

To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.

Full description

3 groups.

Group (C) / (I):20 patient (control group) :

Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.

Group (D)/ (II) :20 patient (Dexmetonidine group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.

Group (M) / (III) : 20 patient (magnesium slphate group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.

Enrollment: 60 estimated patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female patient
• American society of anesthesiologists (ASA) I and II physical status
• age from 25 to 70 years old
• scheduled for either left or right modified radical mastectomy (MRM).

Exclusion criteria

• infection of the skin at or near site of needle puncture
• coagulopathy
• drug hypersensitivity or allergy to the studied drugs
• central or peripheral neuropathy
• significant organ dysfunction cardiac dysrrhythmias
• obesity (BMI>35kg/m2)
• recently use analgesic drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Group (C) (control group):

Placebo Comparator group

Description:

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.

Treatment:

Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy

Group (D) (Dexmetonidine group):

Active Comparator group

Description:

Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5..

Treatment:

Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy

Group (M) (magnesium slphate group):

Active Comparator group

Description:

Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5..

Treatment:

Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy