Analgesic Effect of Levobupivacaine in Breast Augmentation

NCT ID: NCT02465008

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2016-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

levobupivaciane group

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).

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

Placebo Comparator (saline solution)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Levobupivacaine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

General University Hospital of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Severiano Marin Bertoli

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PERPRO2014_V2

Identifier Type: -

Identifier Source: org_study_id