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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
Inactive light
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.
Time frame: 24 hours post-operative
Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'
Time frame: 24 hours
Swelling Evaluation Through Length by Width Breast Diameter Measurements
Time frame: immediately, 24 hours & 7 days post surgery
Self-reported Degree of Pain Rating in the Breasts Area.
Time frame: 24 hours, 7 days, 14 days & 28 days post surgery
Use of Pain Management Medication Post-surgically.
Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.
Time frame: Through the 1st 7 post-operative days.
Hydration Level Assessment
Time frame: immediately, 24 hours & 7 days post surgery.
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Infection Evaluation
Time frame: 24 hours & 7 days post surgery
Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
Time frame: 7 days post surgery