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

Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial

*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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Dexamethasone; Other: Normal Saline

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mahmoud AA ElShourbagy, MD; Phone Number: +201001448189; Email: elshourbagym22@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams Maternity Hospital
    • Contact: Mahmoud AA ElShourbagy, MD; Phone Number: +201001448189; Email: elshourbagym22@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (D); will include 50 women who will receive intravenous dexamethasone.	Drug: Dexamethasone; Intravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia.; Other Names: Decadron
Placebo Comparator: Group (C); will include 50 women who will receive intravenous normal saline (0.9 %).	Other: Normal Saline; Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Collaborators: Ain Shams University
• Investigators: Study Chair: Mahmoud AA ElShourbagy, MD, Professor of Obstetrics and Gynecology; Study Director: Dalia A Nasr, MD, Professor of Anesthesia, Intensive Care and Pain; Study Director: Bassem A Islam, MD, Lecturer in Obstetrics & Gynecology; Principal Investigator: Abdelhameed AA Ismail, MBBCh, Resident of Obstetrics & Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Intravenous Dexamethasone; Post-cesarean Section Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: IVD-SA-CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No