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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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].

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Dexamethasone groupExperimental treatment 1 intervention
Group C: Magnesium groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24 hours postoperatively

Secondary outcomes

1

Degree of pain

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.

Time frame
24 hours postoperatively
2

Obstetric Quality of Recovery

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.

Time frame
24 hours postoperatively
3

Total morphine consumption

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 frame
24 hours postoperatively
4

Time to independent movement

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).

Time frame
24 hours postoperatively

Other outcomes

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