Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia

NCT ID: NCT07139522

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-12-01

Brief Summary

This study aims to compare the efficacy of adding dexamethasone and magnesium sulfate as an adjuvant to bupivacaine in bilateral erector spinae block in postoperative pain control in patients undergoing caesarean section under spinal anesthesia.

Detailed Description

Caesarean section (CS) is the most common abdominal surgery among women worldwide. Inadequately treated postoperative pain can contribute significantly to morbidity of surgical patients, resulting in the delay of patients' recovery and ability to return to daily functional activities, increased incidence of chronic pain, and post-traumatic stress syndrome.

The ultrasound-guided erector spinae plane (ESP) block is a recently described interfascial paraspinal plane technique that was initially used by Forero et al. for providing thoracic analgesia when performed at the level of T5 transverse process. Since the pain experienced after caesarean delivery using a Pfannenstiel incision has both a somatic and visceral component.

Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics.

Dexamethasone is a potent glucocorticoid medication commonly used as an adjuvant to reduce postoperative pain. The mechanisms of perineurally administered dexamethasone are likely attributed to complex interactions, including direct inhibition of signal transmission in nociceptive C fibres, local vasoconstriction, and reduced local inflammation.

Conditions

Dexamethasone; Magnesium Sulphate; Adjuvant; Ultrasound; Erector Spinae Plane Block; Postoperative Analgesia; Cesarean Section; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients will receive 20 ml 0.25% isobaric bupivacaine.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Patients will receive 20 ml of 0.25% isobaric bupivacaine.

Dexamethasone group

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).

Magnesium group

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).

Group Type: EXPERIMENTAL

Magnesium sulphate

Intervention Type: DRUG

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).

Interventions

Bupivacaine

Patients will receive 20 ml of 0.25% isobaric bupivacaine.

Intervention Type: DRUG

Dexamethasone

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).

Intervention Type: DRUG

Magnesium sulphate

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 35 years.
• Full-term, singleton, pregnant women.
• American Society of Anesthesiologists (ASA) physical status II.
• Scheduled for elective cesarean delivery under spinal anesthesia.

Exclusion Criteria

• Refusal of the patient.
• Emergency caesarean sections.
• Patients having chronic diseases as asthma, cardiovascular disorders (Significant arrhythmias, Severe Valvular diseases, congenital heart diseases, ischemic heart disease, cardiomyopathy, deep venous thrombosis ,and pulmonary embolism)
• Renal impairment (Creatinine level ≥ 2mg/dl, urea ≥ 25mg/dL), liver impairment [Alanine aminotransferase (ALT) < 45 U/L, Aspartate aminotransferase (AST) < 45 U/L].
• Allergy to the drug enrolled in the study.
• Body mass index (BMI) ≥ 35 kg/m2.
• Hypertensive disorders of pregnancy.
• Contraindication to spinal anesthesia, such as coagulopathy [platelet count <150.000, international normalized ratio (INR) > 1.2], or local infection.
• Requirement for conversion to general anesthesia after spinal anesthesia will also be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Esmaeel Sayed Farrag

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Esraa E Farrag, Master

Role: CONTACT

esraa.es1@gmail.com

00201229244923

Facility Contacts

Esraa E Farrag, Master

Role: primary

esraa.es1@gmail.com

00201229244923

Other Identifiers

MD-344-2023

Identifier Type: -

Identifier Source: org_study_id