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

Early Phase 1

• Conditions: Cesarean Section
• Interventions: Other: Normal Saline; Drug: Dexamethasone

• Registration Number: NCT03122756
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

\*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.

Detailed 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?

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Study Start: 2017-08-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (C)	Normal Saline	will include 50 women who will receive intravenous normal saline (0.9 %).
Group (D)	Dexamethasone	will include 50 women who will receive intravenous dexamethasone.

Primary Outcome Measures

Name	Time	Method
change in post-cesarean pain	2, 4, 8 and 12 hours after the procedure	post-cesarean pain degree scored by the patient on Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
shivering	2, 4, 8 and 12 hours after the procedure	postoperative shivering
vomiting	2, 4, 8 and 12 hours after the procedure	postoperative vomiting
sensory recovery	2, 4, 8 and 12 hours after the procedure	sensory recovery time by cold object
motor recovery	2, 4, 8 and 12 hours after the procedure	motor recovery time on Bromage scale
nausea	2, 4, 8 and 12 hours after the procedure	postoperative nausea

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt