Efficacy of Magnesium Sulfate as an Adjuvant in Erector Spinae Plane Block as an Anesthetic Post Operative After Modified Radical Mastectomy

NCT ID: NCT05976464

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2025-08-25

Brief Summary

efficacy of magnesium sulfate as an adjuvant in erector spinae plane block as an anesthetic post-operative after modified radical mastectomy

Detailed Description

magnesium sulphate as an adjuvant to local anesthetic in erector spinae plane block compared to local anesthetic only in erector spinae plane block

Conditions

ESPB, Mg Sulfate,Post Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

magnesium sulphate as an adjuvant to local anesthetic in erector spinae plane block

Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate in erector spinae plane block

Intervention Type: DRUG

Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with l/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium and inhalational anesthesia (sevoflurane) No other narcotic, analgesic or sedative will be administrated during the operative period.

BP(SystolicBP, DiastolicBP) and HR will be observed and recorded every 30 min till the end of surgery.

local anesthetic only in erector spinae plane block

Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine and magnesium sulfate into interfacial plane below erector spinae muscle.

Group Type: EXPERIMENTAL

Magnesium sulfate in erector spinae plane block

Intervention Type: DRUG

Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with l/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium and inhalational anesthesia (sevoflurane) No other narcotic, analgesic or sedative will be administrated during the operative period.

BP(SystolicBP, DiastolicBP) and HR will be observed and recorded every 30 min till the end of surgery.

Interventions

Magnesium sulfate in erector spinae plane block

Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with l/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium and inhalational anesthesia (sevoflurane) No other narcotic, analgesic or sedative will be administrated during the operative period.

BP(SystolicBP, DiastolicBP) and HR will be observed and recorded every 30 min till the end of surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. ASA I-II. 2. Female patients aged 18-65 years. 3. Scheduled for a modified radical mastectomy with axillary dissection for breast cancer.

Exclusion Criteria

1. ASA < II.

2. more than 65 years old

3. Patients with known allergies to the study drugs

4. Skin infection at the site of needle puncture.

5. Coagulopathy

5. Drug or as that would interfere with perception and assessment of pain. 6. Uncooperative patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Doha Mohamed Ahmed, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed a.m bakr, professor

Role: STUDY_CHAIR

professor of anesthesia

Locations

Assuit University -South Egypt Cancer Institute

Asyut, Assuit, Egypt

Countries

Egypt

Other Identifiers

magnesium analgesic efficacy

Identifier Type: -

Identifier Source: org_study_id