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

Cairo University (CU)

Status: Enrolling

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

Treatments: Drug: Bupivacaine; Drug: Magnesium sulphate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07139522

MD-344-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Control group

Active Comparator group

Description:

Patients will receive 20 ml 0.25% isobaric bupivacaine.

Treatment:

Drug: Bupivacaine

Dexamethasone group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Magnesium group

Experimental group

Description:

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

Treatment:

Drug: Magnesium sulphate