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

NCT07139522 | Recruiting

• 1 other identifier: MD-344-2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic requirement

  Time to first analgesic requirement in the following 24 hours after cesarean delivery. It is the time elapsed between performing the assigned intervention and first morphine requirement.

  24 hours postoperatively

Secondary Outcomes (5)

• Degree of pain

  24 hours postoperatively

• Obstetric Quality of Recovery

  24 hours postoperatively

• Total morphine consumption

  24 hours postoperatively

• Time to independent movement

  24 hours postoperatively

• Incidence of complications

  24 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients will receive 20 ml 0.25% isobaric bupivacaine.

Drug: Bupivacaine

Dexamethasone group

EXPERIMENTAL

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

Drug: Dexamethasone

Magnesium group

EXPERIMENTAL

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

Drug: Magnesium sulphate

Interventions

Bupivacaine DRUG

Patients will receive 20 ml of 0.25% isobaric bupivacaine.

Control group

Dexamethasone DRUG

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

Dexamethasone group

Magnesium sulphate DRUG

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

Magnesium group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women undergoing elective cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Dexamethasone; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Esraa E Farrag, Master

CONTACT

00201229244923; esraa.es1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)