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

Study Overview
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Brief Summary
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*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
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*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?

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

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Dexamethasone
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (D)<br>will include 50 women who will receive intravenous dexamethasone. | Drug: Dexamethasone<br>* 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.<br>* Other names: Decadron;|
| Placebo Comparator: Group (C)<br>will include 50 women who will receive intravenous normal saline (0.9 %). | Other: Normal Saline<br>* Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous Dexamethasone, Spinal Anesthesia, Post-cesarean Section Pain