Analgesic Effect of Levobupivacaine in Breast Augmentation

Phase 4

Suspended

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Levobupivacaine

• Registration Number: NCT02465008
• Lead Sponsor: General University Hospital of Valencia

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.

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-08
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator (saline solution)	Placebo	Placebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively).
levobupivaciane group	Levobupivacaine	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).

Primary Outcome Measures

Name	Time	Method
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)