Analgesic Effect of Levobupivacaine in Breast Augmentation

NCT02465008 | Suspended Phase 4

• 1 other identifier: PERPRO2014_V2
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain

Keywords

postoperative; Patient-reported

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

levobupivaciane group

EXPERIMENTAL

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).

Drug: Levobupivacaine

Placebo Comparator (saline solution)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Levobupivacaine DRUG

levobupivaciane group

Placebo DRUG

Placebo Comparator (saline solution)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women\> 18 and \<= 65 years
• Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
• ASA I and II
• Informed consent signed

You may not qualify if:

• Rejection of the patient
• ASA III or higher
• Allergy to NSAIDs, local anesthetics and / or morphine
• Patients treated for chronic pain
• Placement of drains for surgical needs

Sponsors & Collaborators

• General University Hospital of Valencia: lead

MeSH Terms

Conditions

Pain

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07