Clinical trial

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

Name

magnesium analgesic efficacy

Description

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

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-10-01

Trial end

2024-12-15

Status

Not yet recruiting

Phase

Early phase I

Treatment

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.

Arms:

erector spinae plane block, magnesium sulfate as an adjuvant in erector spinae plane block

Size

Primary endpoint

- The primary outcome measure in this study will be the total dose of morphine consumption during the 24 hour Postoperatively.

Up to 24 hour

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-03-04

1 organization

1 product

2 indications

Organization

Product

Indication

Indication