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NCT Number: NCT07139522

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

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.

Recruiting

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Ahmed El Saqa, MD

SUB_INVESTIGATOR

Esraa E Farrag, Master

CONTACT

[email protected]

00201229244923

Hagar H Refaee, MD

SUB_INVESTIGATOR

Hala A Elsabbagh, MD

SUB_INVESTIGATOR

Nesrine El Refaei, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

Patients will receive 20 ml of 0.25% isobaric bupivacaine.

Dexamethasone

Drug

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

Magnesium sulphate

Drug

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

Primary outcomes

  1. Time to first analgesic requirement

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be recorded at 1, 2, 4, 6,18 and 24 h postoperatively.

  2. Obstetric Quality of Recovery

    Time frame: 24 hours postoperatively

    Obstetric Quality of Recovery (ObsQore) aims to measure functional recovery at 24 hours postpartum quantitatively. It includes 11 questions on a 0 to 11 scale, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing, aimed at pain management, the adverse effects of narcotics, and the perception of recovery by the patient.

  3. Total morphine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia in the form of morphine 0.05 mg/kg will be given when the Visual Analogue Scale (VAS) is more than 3, with a total maximum of 20mg morphine / 24hrs.

  4. Time to independent movement

    Time frame: 24 hours postoperatively

    Time to independent movement defined as time from performing the intervention to be able independently mobile e.g. using the bathroom, care for the baby).

  5. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as nausea, vomiting, itching, urine retention, sedation (opioid sedation score), (respiratory depression (respiratory rate less than 8 breath per minute) and lower limb weakness will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa E Farrag, Master

CONTACT

[email protected]

00201229244923

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Efficacy of 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: A Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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