Dexamethasone versus magnesium added to bupivacaine for erector spinae plane block after elective cesarean
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.
This study will test whether adding dexamethasone or magnesium sulfate to bupivacaine in an erector spinae plane block gives better pain relief after elective cesarean under spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07139522 on ClinicalTrials.gov |
What this trial studies
Investigators will compare the effects of adding either dexamethasone or magnesium sulfate to bupivacaine for bilateral ultrasound-guided erector spinae plane (ESP) blocks in women having elective cesarean delivery under spinal anesthesia. Participants will receive the ESP block with bupivacaine plus one of the adjuvants and postoperative outcomes such as pain scores, duration of analgesia, and opioid consumption will be recorded. The ESP block is an interfascial paraspinal technique intended to provide both somatic and visceral pain relief for Pfannenstiel incisions. The goal is to identify which adjuvant prolongs and improves postoperative analgesia with acceptable safety.
Who should consider this trial
Good fit: Ideal candidates are full-term, singleton pregnant women aged 18–35 years with ASA physical status II who are scheduled for elective cesarean delivery under spinal anesthesia.
Not a fit: Patients having emergency cesarean sections, significant chronic medical conditions, hypertensive disorders of pregnancy, high BMI (≥35), contraindications to spinal anesthesia, or known allergy to the study drugs are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this could give longer and better pain control after cesarean delivery and reduce the need for opioids.
How similar studies have performed: Previous studies commonly report that perineural dexamethasone prolongs local anesthetic effects while magnesium sulfate has shown mixed but sometimes positive results as an analgesic adjuvant.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Esraa E Farrag, Master
- Email: esraa.es1@gmail.com
- Phone: 00201229244923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.