N/A
N=104
Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00926887 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. — 20; 37 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia(R) EML Laser (Device); Placebo Laser (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Erchonia Corporation
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. |
20; 37 | <0.0001 sig |
| PRIMARY Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. |
36.78; 21.40 | <0.001 sig |
| SECONDARY Swelling Evaluation Through Length by Width Breast Diameter Measurements |
— | — |
| SECONDARY Self-reported Degree of Pain Rating in the Breasts Area. |
— | — |
| SECONDARY Use of Pain Management Medication Post-surgically. |
20.26; 18.43 | <0.01 sig |
| SECONDARY Hydration Level Assessment |
— | — |
| SECONDARY Infection Evaluation |
— | — |
| SECONDARY Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00926887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.