NCT02112422

Brief Summary

The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves quality of recovery in patients undergoing elective cesarean section as compared to the same dose given immediately prior to skin incision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

April 8, 2014

Last Update Submit

April 29, 2015

Conditions

Pregnancy

Keywords

Parturients

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain using visual analogue score.

    24 hours

Secondary Outcomes (1)

  • Number of episodes of Nausea and Vomiting

    24 hours post-operative

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR. The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.

Drug: Control

Intervention

EXPERIMENTAL

Patients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR. The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.

Drug: Intervention

Interventions

ControlDRUG

The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.

Also known as: 0.15 mg/kg dexamethasone IV prior to skin incision.
Control
InterventionDRUG

Patients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR.

Also known as: 0.15 mg/kg of dexamethasone IV 60 minutes prior to the OR.
Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years of age
  • American Society of Anesthesiologists class I-III
  • Presenting for elective cesarean section.

You may not qualify if:

  • Contraindication to regional anesthesia
  • Allergy to study drug
  • Uncontrolled diabetes
  • Active infection
  • Adrenal axis pathology
  • Active treatment with steroids
  • Treatment with oral or parenteral steroids within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Sciences Center

Winnipeg, Manitoba, R3A1R9, Canada

Location

Winnipeg Health Sciences Center

Winnipeg, Manitoba, R3Y-0A9, Canada

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Duane J Funk, MD FRCP(C)

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

CA(2)