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

SEBASTIAN ROCHE

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacaine- physiological solution; Drug: Bupivacaine-Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03007927

2736

Details and patient eligibility

About

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

Full 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

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Bupivacaine-Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine-Dexamethasone

Bupivacaine- physiological solution

Active Comparator group

Description:

bupivacaine 1,5 mg/kg + physiological solution

Treatment:

Drug: Bupivacaine- physiological solution