NCT03007927

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
Last Updated

February 22, 2018

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

December 20, 2016

Last Update Submit

February 20, 2018

Conditions

Pain, Postoperative

Keywords

painhernia repairDexamethasone

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month

Secondary Outcomes (1)

  • take analgesic

    1 month

Study Arms (2)

Bupivacaine-Dexamethasone

EXPERIMENTAL

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

Drug: Bupivacaine-Dexamethasone

Bupivacaine- physiological solution

ACTIVE COMPARATOR

bupivacaine 1,5 mg/kg + physiological solution

Drug: Bupivacaine- physiological solution

Interventions

Bupivacaine-DexamethasoneDRUG

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

Bupivacaine-Dexamethasone
Bupivacaine- physiological solutionDRUG

Bupivacaine 1,5 mg/kg- physiological solution

Bupivacaine- physiological solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires, Peron 4190

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

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sebastian SR Roche, doctor

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 2, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 29, 2017

Last Updated

February 22, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations

AR(1)