Analgesic Effect of Levobupivacaine in Breast Augmentation

General University Hospital of Valencia

Status and phase: Suspended; Phase 4

Conditions: Pain

Treatments: Drug: Levobupivacaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02465008

PERPRO2014_V2

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

levobupivaciane group

Experimental group

Description:

Levobupivacaine group (L- bupivacaine 0,25% -2,5 mg/ml-) 60 ml. Total dosis in topical use 150 mg (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively).

Treatment:

Drug: Levobupivacaine

Placebo Comparator (saline solution)

Placebo Comparator group

Description:

Placebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively).

Treatment:

Drug: Placebo