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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03007927
Enrollment
82
Registered
2017-01-02
Start date
2016-08-31
Completion date
2017-06-29
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

pain, hernia repair, Dexamethasone

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

Interventions

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

DRUGBupivacaine- physiological solution

Bupivacaine 1,5 mg/kg- physiological solution

Sponsors

Sebastián Roche, MD
CollaboratorUNKNOWN
Santiago Bertone, MD
CollaboratorUNKNOWN
Claudio Brandi, MD
CollaboratorUNKNOWN
SEBASTIAN ROCHE
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
pain postoperative3 monthIt 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

MeasureTime frameDescription
take analgesic1 monthMedication journal completed by patient

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026