Overview

Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
BB 1101
Bupivacaine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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