NCT02440880

Brief Summary

Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction. This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started May 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

April 24, 2015

Last Update Submit

August 2, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • level of pain according to verbal analogue scale

    THREE DAYS

Study Arms (5)

CONTROL

PLACEBO COMPARATOR

TAP block without Dexamethasone neither intravenous nor in combination with the block

Other: control

Group 2 (TD8IS)

EXPERIMENTAL

Dexamethasone in combination with TAP block in dose of 8 mg

Drug: Dexamethasone in combination with TAP block in dose of 8 mg

Group 3(TD4IS)

EXPERIMENTAL

Dexamethasone in addition to TAP block in dose of 4 mg

Drug: Dexamethasone in addition to TAP block in dose of 4 mg

Group 4 (TSID8):

EXPERIMENTAL

Dexamethasone intravenous in addition to TAP block in dose of 8 mg

Drug: Dexamethasone intravenous in addition to TAP block in dose of 8 mg

Group5(TSID4)

EXPERIMENTAL

Dexamethasone intravenous 4mg+ TAP block

Drug: Dexamethasone intravenous 4mg+ TAP block

Interventions

Dexamethasone in addition to TAP block in dose of 4 mgDRUG

Dexamethasone in addition to TAP block in dose of 4 mg

Group 3(TD4IS)
Dexamethasone in combination with TAP block in dose of 8 mgDRUG

Dexamethasone in combination with TAP block in dose of 8 mg

Group 2 (TD8IS)
Dexamethasone intravenous 4mg+ TAP blockDRUG

Dexamethasone intravenous in addition to TAP block in dose of 4 mg

Also known as: Dexamethasone intravenous 4mg + TAP block
Group5(TSID4)
Dexamethasone intravenous in addition to TAP block in dose of 8 mgDRUG

Dexamethasone intravenous + TAP block in dose of 8 mg

Also known as: Dexamethasone intravenous 8mg+ TAP block
Group 4 (TSID8):
controlOTHER

TAP block without Dexamethasone neither intravenous nor in combination with the block

Also known as: control group
CONTROL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Any patient ASA (american society of anesthesia) I or II,
  • aged between 18 and 45 scheduled for elective cesarean section.

You may not qualify if:

  • patient refusal,
  • age below 18 or above 45 years,
  • coagulopathy with INR (international normalized ratio) more than 1.5 or platelets below 100000,
  • uncontrolled diabetes, uncontrolled hypertensive, addict patient,
  • psychological instability, and
  • allergy to the used drugs,
  • failure of spinal,
  • conversion to general of anesthesia,
  • failure of application of TAP block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

DexamethasoneControl Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hassan Ali, LECTURER

    Anesthesia department, faculty of medicine ,Cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hassan Ali

CONTACT

+201001733687hassan364@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in anesthesia department Cairo university

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

EG(1)