Pain
Conditions
Keywords
postoperative, Patient-reported
Brief summary
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation
Detailed description
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.
Interventions
DRUGLevobupivacaine
DRUGPlacebo
Sponsors
General University Hospital of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough). | at 6 hours the early postoperative period (after the end of anesthesia) |
Outcome results
None listed