Clinical trial NCT00926887: Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
Official title: A Double-Blind, Randomized, Placebo-Controlled Evaluation of the Effect of the Erchonia(R) EML Laser on Reducing Pain Following Breast Augmentation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.
timeFrame: 24 hours post-operative
measure: Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.
timeFrame: 24 hours
Secondary outcomes:
measure: Swelling Evaluation Through Length by Width Breast Diameter Measurements
timeFrame: immediately, 24 hours & 7 days post surgery
measure: Self-reported Degree of Pain Rating in the Breasts Area.
timeFrame: 24 hours, 7 days, 14 days & 28 days post surgery
measure: Use of Pain Management Medication Post-surgically.
timeFrame: Through the 1st 7 post-operative days.
measure: Hydration Level Assessment
timeFrame: immediately, 24 hours & 7 days post surgery.
measure: Infection Evaluation
timeFrame: 24 hours & 7 days post surgery
measure: Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
timeFrame: 7 days post surgery
Other outcomes:
Locations:
Study officials:
name: Robert F Jackson, MD, FACS
role: PRINCIPAL_INVESTIGATOR
name: Gregory Roche, DO
role: PRINCIPAL_INVESTIGATOR
name: Thomas L Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: