Clinical trial NCT03122756: Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain
Official title: Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cesarean Section
Keywords: Intravenous Dexamethasone
Spinal Anesthesia
Post-cesarean Section Pain
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2017-04-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility 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.

Primary outcomes:
measure: change in post-cesarean pain
timeFrame: 2, 4, 8 and 12 hours after the procedure
Secondary outcomes:
measure: sensory recovery
timeFrame: 2, 4, 8 and 12 hours after the procedure
measure: motor recovery
timeFrame: 2, 4, 8 and 12 hours after the procedure
measure: nausea
timeFrame: 2, 4, 8 and 12 hours after the procedure
measure: vomiting
timeFrame: 2, 4, 8 and 12 hours after the procedure
measure: shivering
timeFrame: 2, 4, 8 and 12 hours after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Professor of Obstetrics and Gynecology
name: Mahmoud AA ElShourbagy, MD
role: STUDY_CHAIR
affiliation: Professor of Anesthesia, Intensive Care and Pain
name: Dalia A Nasr, MD
role: STUDY_DIRECTOR
affiliation: Lecturer in Obstetrics & Gynecology
name: Bassem A Islam, MD
role: STUDY_DIRECTOR
affiliation: Resident of Obstetrics & Gynecology
name: Abdelhameed AA Ismail, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: