Adjuvant, Cesarean Section, Dexamethasone, Erector Spinae Plane Block, Magnesium Sulphate, Postoperative Analgesia, Spinal Anesthesia, Ultrasound
Conditions
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.
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
DRUGBupivacaine
Patients will receive 20 ml of 0.25% isobaric bupivacaine.
DRUGDexamethasone
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).
DRUGMagnesium sulphate
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic requirement | 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
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 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. |
| Obstetric Quality of Recovery | 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. |
| Total morphine consumption | 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. |
| Time to independent movement | 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). |
| Incidence of complications | 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. |
Countries
Egypt
Contacts
Primary ContactEsraa E Farrag, Master
Outcome results
None listed