drugset / Trial / NCT02784340

Local and Intravenous Dexamethasone on Post Operative Pain a After CS

NCT02784340 ↗

Phase 4 Completed 120 enrolled Cairo University
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2014-05
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 16 mg Intravenous
Comparator Bupivicaine Other / unclassified 10 mg Intrathecal
Comparator Fentanyl Other / unclassified 20 ug Intrathecal

Indications

No indication recorded.