Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh

February 20, 2018 updated by: SEBASTIAN ROCHE
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be: controlled, prospective, randomized and double blind.

Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:

(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.

(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.

Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .

It will also evaluate analgesic consumption, complications and labor return

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Argentina
    • Capital Federal
      • Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires, Peron 4190

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients older than 18 years.
  2. Unilateral inguinal hernioplasty.
  3. That the surgery is performed in the Ambulatory Surgery Unit (UCA).

Exclusion Criteria:

  1. Recurrent hernia.
  2. allergies, ongoing infections, diabetes.
  3. Background of rejection of prosthetic material (mesh).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine-Dexamethasone
bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
Drug: Bupivacaine-Dexamethasone
Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
Active Comparator: Bupivacaine- physiological solution
bupivacaine 1,5 mg/kg + physiological solution
Drug: Bupivacaine- physiological solution
Bupivacaine 1,5 mg/kg- physiological solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain postoperative
Time Frame: 3 month
It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
take analgesic
Time Frame: 1 month
Medication journal completed by patient
1 month

Collaborators and Investigators

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

Sponsor

SEBASTIAN ROCHE

Collaborators

Sebastián Roche, MD
Santiago Bertone, MD
Claudio Brandi, MD

Investigators

  • Principal Investigator: Sebastian SR Roche, doctor, Hospital Italiano de Buenos Aires

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

August 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 29, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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