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
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine, Dexamethasone, Magnesium sulphate.
- Who it may be relevant to
- Registry conditions: Dexamethasone, Magnesium Sulphate, Adjuvant, Ultrasound. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Drug Bupivacaine
Patients will receive 20 ml of 0.25% isobaric bupivacaine. - Drug Dexamethasone
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone). - Drug Magnesium sulphate
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).
Primary outcome measures
- Time to first analgesic requirement [Time frame: 24 hours postoperatively]
Secondary outcome measures (5)
- Degree of pain [Time frame: 24 hours postoperatively]
- Obstetric Quality of Recovery [Time frame: 24 hours postoperatively]
- Total morphine consumption [Time frame: 24 hours postoperatively]
- Time to independent movement [Time frame: 24 hours postoperatively]
- Incidence of complications [Time frame: 24 hours postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07139522 · MD-344-2023