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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05976464

Collaborator

(none)

Enrollment

Arms

1.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ESPB, Mg Sulfate,Post Mastectomy	Drug: Magnesium sulfate in erector spinae plane block	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

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.

Arm

Intervention/Treatment

Active Comparator: erector spinae plane block

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

Outcome Measures

Primary Outcome Measures

- 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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

ASA < II.
more than 65 years old
Patients with known allergies to the study drugs
Skin infection at the site of needle puncture.
Coagulopathy
Drug or as that would interfere with perception and assessment of pain. 6. Uncooperative patients.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Doha Mohamed Ahmed, MD, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05976464

Other Study ID Numbers:

magnesium analgesic efficacy

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Magnesium Sulfate

Study Results

No Results Posted as of Aug 4, 2023