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

Efficacy of Magnesium Sulfate as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block for Post-operative Analgesia After Modified Radical Mastectomy

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

Study Overview

• Status: Not yet recruiting
• Conditions: ESPB, Mg Sulfate,Post Mastectomy
• Intervention / Treatment: Drug: Magnesium sulfate in erector spinae plane block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Experimental: magnesium sulfate as an adjuvant 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- The primary outcome measure in this study will be the total dose of morphine consumption during the 24 hour Postoperatively.	Up to 24 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: magnesium analgesic efficacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No