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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007927
• Other study ID #: 2736
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2016
• Last updated: February 20, 2018
• Start date: August 2016
• Est. completion date: June 29, 2017

Study information

• Verified date: August 2017
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 29, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine-Dexamethasone
Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
• Bupivacaine- physiological solution
Bupivacaine 1,5 mg/kg- physiological solution

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires, Peron 4190	Ciudad Autonoma de Buenos Aires	Capital Federal

Sponsors (4)

Lead Sponsor	Collaborator
SEBASTIAN ROCHE	Claudio Brandi, MD, Santiago Bertone, MD, Sebastián Roche, MD

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	take analgesic	Medication journal completed by patient	1 month