Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section

August 2, 2016 updated by: Hassan Mohamed Ali, Cairo University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.(1,2,3) The presence of the adjuvant which can be added to the conventional anesthetic medications can prolong the duration of action and decrease the need for frequent post-operative analgesics.(4,5) The idea of adding a catheter or placing an epidural catheter still have a quite limitation regarding the patients compliance, delayed ambulation and high costs, these limitations redirect the anesthetist again to the use of adjuvant with a single shot block to prolong the duration of it and decrease the need of subsequent analgesics.(6) Dexamethasone proved to be an effective adjuvant in prolongation of the nerve blocks with the question regarding the proper route and dose (7,8,9,10).

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 1234
        • Recruiting
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: CONTROL
TAP block without Dexamethasone neither intravenous nor in combination with the block
Other: control
TAP block without Dexamethasone neither intravenous nor in combination with the block
Other Names:
  • control group
EXPERIMENTAL: Group 2 (TD8IS)
Dexamethasone in combination with TAP block in dose of 8 mg
Drug: Dexamethasone in combination with TAP block in dose of 8 mg
Dexamethasone in combination with TAP block in dose of 8 mg
EXPERIMENTAL: Group 3(TD4IS)
Dexamethasone in addition to TAP block in dose of 4 mg
Drug: Dexamethasone in addition to TAP block in dose of 4 mg
Dexamethasone in addition to TAP block in dose of 4 mg
EXPERIMENTAL: Group 4 (TSID8):
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
Dexamethasone intravenous + TAP block in dose of 8 mg
Other Names:
  • Dexamethasone intravenous 8mg+ TAP block
EXPERIMENTAL: Group5(TSID4)
Dexamethasone intravenous 4mg+ TAP block
Drug: Dexamethasone intravenous 4mg+ TAP block
Dexamethasone intravenous in addition to TAP block in dose of 4 mg
Other Names:
  • Dexamethasone intravenous 4mg + TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of pain according to verbal analogue scale
Time Frame: THREE DAYS
THREE DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Hassan Ali, LECTURER, Anesthesia department, faculty of medicine ,Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (ESTIMATE)

May 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qasr Elainy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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