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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Bupivacaine-Dexamethasone
Bupivacaine- physiological solution
Sponsored by
SEBASTIAN ROCHE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring pain, hernia repair, Dexamethasone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Hospital Italiano de Buenos Aires, Peron 4190

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bupivacaine-Dexamethasone

Bupivacaine- physiological solution

Arm Description

bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml

bupivacaine 1,5 mg/kg + physiological solution

Outcomes

Primary Outcome Measures

pain postoperative
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 Outcome Measures

take analgesic
Medication journal completed by patient

Full Information

First Posted
December 20, 2016
Last Updated
February 20, 2018
Sponsor
SEBASTIAN ROCHE
Collaborators
Sebastián Roche, MD, Santiago Bertone, MD, Claudio Brandi, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03007927
Brief Title
Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Official Title
Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SEBASTIAN ROCHE
Collaborators
Sebastián Roche, MD, Santiago Bertone, MD, Claudio Brandi, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain, hernia repair, Dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine-Dexamethasone
Arm Type
Experimental
Arm Description
bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
Arm Title
Bupivacaine- physiological solution
Arm Type
Active Comparator
Arm Description
bupivacaine 1,5 mg/kg + physiological solution
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Dexamethasone
Intervention Description
Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine- physiological solution
Intervention Description
Bupivacaine 1,5 mg/kg- physiological solution
Primary Outcome Measure Information:
Title
pain postoperative
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
take analgesic
Description
Medication journal completed by patient
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian SR Roche, doctor
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires, Peron 4190
City
Ciudad Autonoma de Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1199ABB
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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