Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Study Overview
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Brief Summary
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A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications

Detailed Description
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The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age. Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms. All surgeons had close surgical skills and used the same technique transverse lower segment incision. The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.

Official Title
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Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Dexamethasone
* Drug: Saline (IV fluids)
* Drug: Bupivicaine and Fentany
* Device: 25G spinal needles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants were scheduled for elective cesarean section under spinal anaesthesia Exclusion Criteria: Women with neurological disorders Psychologically disturbed Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma Women with systemic infections Allergy to Dexamethasone Contraindications to spinal anaesthesia

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV dexamethasone<br>40 women received 16 mg Dexamethasone IV drip. | Drug: Dexamethasone<br>* 16 mg Dexamethasone IV drip<br>* Other names: dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt;Drug: Bupivicaine and Fentany<br> <br> Device: 25G spinal needles<br> <br> |
| Active Comparator: Local dexamethasone<br>40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure | Drug: Dexamethasone<br>* 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure<br>* Other names: dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt;Drug: Bupivicaine and Fentany<br> <br> Device: 25G spinal needles<br> <br> |
| Placebo Comparator: placebo<br>Placebo in the form of IV fluids 500 cc saline infusion | Drug: Saline (IV fluids)<br>* IV fluids 500 cc saline infusion<br>* Other names: saline infusion;Drug: Bupivicaine and Fentany<br> <br> Device: 25G spinal needles<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score visual acoustic score | Subjective description of the pain using questionaire | 48 hours after CS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for additional analgesics |  | 48 hours after CS | 
| Blood pressure |  | 48 hours after CS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, dexamethasone, cesarean section