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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03122756
• Other study ID #: IVD-SA-CS
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2017
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Ain Shams Maternity Hospital
• Contact: Mahmoud AA ElShourbagy, MD
• Phone: +201001448189
• Email: elshourbagym22[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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:
• Normal Saline
Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sensory recovery	sensory recovery time by cold object	2, 4, 8 and 12 hours after the procedure
Secondary	motor recovery	motor recovery time on Bromage scale	2, 4, 8 and 12 hours after the procedure
Secondary	nausea	postoperative nausea	2, 4, 8 and 12 hours after the procedure
Secondary	vomiting	postoperative vomiting	2, 4, 8 and 12 hours after the procedure
Secondary	shivering	postoperative shivering	2, 4, 8 and 12 hours after the procedure