Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain

Ain Shams Maternity Hospital

Status and phase: Unknown; Early Phase 1

Conditions: Cesarean Section

Treatments: Other: Normal Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03122756

IVD-SA-CS

Details and patient eligibility

About

*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.

Full description

*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.

*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • A gestational age of 38 weeks or more and planned for elective cesarean section.
  • Living fetus.
  • Any number of previous cesarean section.
  • Intact amniotic membranes.
  • No history of bleeding tendency.

• Exclusion Criteria:

  • Refuse to participate after counseling.
  • Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).
  • High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).
  • Contraindication to corticosteroids e.g. systemic fungal infection
  • Steroid medication one week before the operation.
  • Chronic pain or daily intake of analgesic.
  • Abnormal placentation e.g. placenta previa.
  • Intrauterine infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Group (D)

Experimental group

Description:

will include 50 women who will receive intravenous dexamethasone.

Treatment:

Drug: Dexamethasone

Group (C)

Placebo Comparator group

Description:

will include 50 women who will receive intravenous normal saline (0.9 %).

Treatment:

Other: Normal Saline