Analgesic Effect of Levobupivacaine in Breast Augmentation

General University Hospital of Valencia66 enrolled

Overview

The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation

One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

LevobupivacaineDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women\> 18 and \<= 65 years * Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane * ASA I and II * Informed consent signed Exclusion Criteria: * Rejection of the patient * ASA III or higher * Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness). * Allergy to NSAIDs, local anesthetics and / or morphine * Patients treated for chronic pain * Placement of drains for surgical needs

Outcomes

Primary Outcomes

Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).

Time frame: at 6 hours the early postoperative period (after the end of anesthesia)

Data from ClinicalTrials.gov

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