Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

Erchonia

Status

Completed

Conditions

Pain

Treatments

Device: Erchonia(R) EML Laser

Device: Placebo Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT00926887

EBA-001

Details and patient eligibility

About

The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.

Full description

Substantial pain, discomfort and swelling following breast augmentation surgery is not uncommon. The ability of low level laser therapy to reduce swelling and inflammation that subsequently reduces pain has been well documented. This study aimed to evaluate the ability of low level laser therapy to reduce post-operative pain and swelling for individuals undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.

Enrollment

104 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Suitability for breast augmentation surgery based on the need for correction of a congenital deformity or condition such as: Amastia, Hypomastia, Hypoplasia, Pectus Carinatum, Pectus Excavatum, OR a cosmetic breast enhancement indication, including: Augmentation to increase breast size, correction of ptotic (drooping) or pendulous (sagging) breasts, recontouring to obtain enhanced breast shape.
Bilateral breast augmentation indication only.
18 to 55 years, inclusive.
Female, only.
Willingness, and ability, to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain and/or swelling, including any non-steroidal anit-inflammatory drugs (NSAIDs), from 48 hours immediately prior to the laser-assisted breast implant procedure through to one week post-procedure.

Exclusion criteria

Breast augmentation procedures indicated for the purpose of breast reconstruction following mastectomy or an injury due to severe trauma.
Presence of a specific connective tissue disorder.
Inadequate tissue available to cover the implants.
Consumption of any one or more of narcotics, opiates, and/or steroids.
Inability to consume the following medications post-operatively due to allergy, intolerance, or any other reason:

(i) Pain medication for the relief of post-operative pain of Lortab 10/500 or another drug within the combination narcotic analgesic drug category within which Lortab falls.

(ii) Antibiotic medication for reducing the risk of post-operative infection of Keflex 500 mg or Cipro 500 mg or another drug within the broad-spectrum antibiotic drug category within which Keflex and Cipro fall.

Developmental disability or cognitive impairment that impacts a subject's ability to read and/or to understand the content of the informed consent form, and/or impacts a subject's ability to read and /or to understand and/or to complete the required case report form information for the clinical study.
Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
Pregnancy or lactation.
Prior surgery to the breast area, or to the area of the intended incision.
Infection or wound in the intended areas of treatment.
Involvement in litigation and/or receiving disability benefits related to the subject's breast(s).
Participation in research over the preceding 90 days.