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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine- physiological solution; Drug: Bupivacaine-Dexamethasone

• Registration Number: NCT03007927
• Lead Sponsor: SEBASTIAN ROCHE

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

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2017-01-02
• Study Completion: 2017-06-29
• Status Verified: 2017-08
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine- physiological solution	Bupivacaine- physiological solution	bupivacaine 1,5 mg/kg + physiological solution
Bupivacaine-Dexamethasone	Bupivacaine-Dexamethasone	bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml

Primary Outcome Measures

Name	Time	Method
pain postoperative	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 Outcome Measures

Name	Time	Method
take analgesic	1 month	Medication journal completed by patient

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires, Peron 4190; 🇦🇷 Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina