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

NCT ID: NCT03007927

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-06-29

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

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine-Dexamethasone

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

Group Type: EXPERIMENTAL

Bupivacaine-Dexamethasone

Intervention Type: DRUG

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

Bupivacaine- physiological solution

bupivacaine 1,5 mg/kg + physiological solution

Group Type: ACTIVE_COMPARATOR

Bupivacaine- physiological solution

Intervention Type: DRUG

Bupivacaine 1,5 mg/kg- physiological solution

Interventions

Bupivacaine-Dexamethasone

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

Intervention Type: DRUG

Bupivacaine- physiological solution

Bupivacaine 1,5 mg/kg- physiological solution

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sebastián Roche, MD

UNKNOWN

Sponsor Role: collaborator

Santiago Bertone, MD

UNKNOWN

Sponsor Role: collaborator

Claudio Brandi, MD

UNKNOWN

Sponsor Role: collaborator

SEBASTIAN ROCHE

OTHER

Sponsor Role: lead

Responsible Party

SEBASTIAN ROCHE

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sebastian SR Roche, doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

Other Identifiers

2736

Identifier Type: -

Identifier Source: org_study_id