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OpenTrials
Completed

NCT Number: NCT03007927

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

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Bupivacaine-Dexamethasone

Drug

Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg

Bupivacaine- physiological solution

Drug

Bupivacaine 1,5 mg/kg- physiological solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. take analgesic

    Time frame: 1 month

    Medication journal completed by patient

Sponsors and collaborators

Lead sponsor

SEBASTIAN ROCHE

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 2, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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