Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine-Dexamethasone
- Conditions
- Pain, Postoperative
- Sponsor
- SEBASTIAN ROCHE
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- pain postoperative
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
SEBASTIAN ROCHE
Medical Doctor
Hospital Italiano de Buenos Aires
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years.
- •Unilateral inguinal hernioplasty.
- •That the surgery is performed in the Ambulatory Surgery Unit (UCA).
Exclusion Criteria
- •Recurrent hernia.
- •allergies, ongoing infections, diabetes.
- •Background of rejection of prosthetic material (mesh).
Arms & Interventions
Bupivacaine-Dexamethasone
bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
Intervention: Bupivacaine-Dexamethasone
Bupivacaine- physiological solution
bupivacaine 1,5 mg/kg + physiological solution
Intervention: Bupivacaine- physiological solution
Outcomes
Primary Outcomes
pain postoperative
Time Frame: 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 Outcomes
- take analgesic(1 month)