NCT02784340

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started May 2014

Typical duration for phase_4 postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

May 20, 2016

Last Update Submit

May 26, 2016

Conditions

Postoperative Pain

Keywords

Postoperative paindexamethasonecesarean section

Outcome Measures

Primary Outcomes (1)

  • VAS score visual acoustic score

    Subjective description of the pain using questionaire

    48 hours after CS

Secondary Outcomes (2)

  • need for additional analgesics

    48 hours after CS

  • Blood pressure

    48 hours after CS

Study Arms (3)

IV dexamethasone

ACTIVE COMPARATOR

40 women received 16 mg Dexamethasone IV drip.

Drug: DexamethasoneDrug: Bupivicaine and FentanyDevice: 25G spinal needles

Local dexamethasone

ACTIVE COMPARATOR

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

Drug: DexamethasoneDrug: Bupivicaine and FentanyDevice: 25G spinal needles

placebo

PLACEBO COMPARATOR

Placebo in the form of IV fluids 500 cc saline infusion

Drug: Saline (IV fluids)Drug: Bupivicaine and FentanyDevice: 25G spinal needles

Interventions

DexamethasoneDRUG

16 mg Dexamethasone IV drip

Also known as: dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt
IV dexamethasone
Saline (IV fluids)DRUG

IV fluids 500 cc saline infusion

Also known as: saline infusion
placebo
Bupivicaine and FentanyDRUG
IV dexamethasoneLocal dexamethasoneplacebo
25G spinal needlesDEVICE
IV dexamethasoneLocal dexamethasoneplacebo

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants were scheduled for elective cesarean section under spinal anaesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Maged AM, Deeb WS, Elbaradie S, Elzayat AR, Metwally AA, Hamed M, Shaker A. Comparison of local and intra venous dexamethasone on post operative pain and recovery after caeseream section. A randomized controlled trial. Taiwan J Obstet Gynecol. 2018 Jun;57(3):346-350. doi: 10.1016/j.tjog.2018.04.004.

    PMID: 29880162DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasonedexamethasone 21-phosphateSodium ChlorideFluid Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDrug TherapyTherapeutics

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share