Analgesic Effect of Levobupivacaine in Breast Augmentation

Pain Clinical Trial

Official title:

Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02465008
• Other study ID #: PERPRO2014_V2
• Status: Suspended
• Phase: Phase 4
• First received: June 3, 2015
• Last updated: July 19, 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Valencia University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 66
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Levobupivacaine

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valencia University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No