NCT04732364

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

Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: South Egypt Cancer Institute · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy	Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
PROCEDURE	ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy	Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
PROCEDURE	ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy	Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle

Timeline

• Start date: 2018-04-30
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2021-02-01
• Last updated: 2021-02-01

Locations

1 site across 1 country: Egypt