Analgesic Effect of Levobupivacaine in Breast Augmentation

Overview

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

Full Title of Study: “Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2016

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

  • Drug: Levobupivacaine
  • Drug: Placebo

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General University Hospital of Valencia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Severiano Marin Bertoli, PhD – General University Hospital of Valencia

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