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Local and Intravenous Dexamethasone on Post Operative Pain a After CS

NCT02784340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-05-27

No results posted yet for this study

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

Conditions

  • Postoperative Pain

Interventions

DRUG

Dexamethasone

16 mg Dexamethasone IV drip

DRUG

Dexamethasone

16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure

DRUG

Saline (IV fluids)

IV fluids 500 cc saline infusion

DRUG

Bupivicaine and Fentany

DEVICE

25G spinal needles

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Kasr Alainy medical school

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784340 on ClinicalTrials.gov