Acute Pain
Conditions
Interventions
The study on the effects of transcutaneous electrical nerve stimulation (TENS) on the intensity of acute postoperative pain in augmentation mammaplasty will use a randomized, placebo-controlled, and d
E02.331.800
Sponsors
Centro de Ciências Biológicas e da Saúde - Universidade Federal de São Carlos
Centro de Ciências Biológicas e da Saúde - Universidade Federal de São Carlos
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women; aged between 18 and 65; Requests for breast augmentation surgery using the 24-hour rapid recovery protocol; report a pain intensity significantly equal to or greater than 3 points on the Numerical Pain Scale in the immediate postoperative period
Exclusion criteria
Exclusion criteria: Chronic diseases; previous experience with electrical currents for pain; history of use of illicit and psychotropic drugs; chronic use of opioids; presence of a cardiac pacemaker; neurological disorders that interfere with the level of consciousness; changes in previous skin sensitivity in the breast; inability to support the shoulder elevated at 90 degrees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Evaluate pain intensity before, immediately after Transcutaneous Electrical Nerve Stimulation (TENS), and during the movement of raising arms to 90 degrees. Method for Outcome Verification: Verified using the Numeric Pain Scale (NPS), ranging from 0 to 10, where zero indicates the absence of pain, and ten represents the worst imaginable pain. Parameters Used for Outcome Verification: A reduction of at least 1 point in pain intensity after the intervention is considered clinically significant | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 6: Assessment of analgesic consumption in the first 4 hours post-surgery Method for Outcome Verification: Recording and evaluating the name of the medication, administration form, dose, and frequency through the hospital evolution sheet and patient's report Parameters Used for Outcome Verification: Conversion of medications to equianalgesic doses of oral morphine (opioids) and acetaminophen (non-opioids) for comparative analysis The difference in consumption between the groups will be determined, allowing an assessment of the impact of Transcutaneous Electrical Nerve Stimulation (TENS) intervention on reducing the need for analgesics;Expected Outcome 2: Assessment of pain intensity one hour after Transcutaneous Electrical Nerve Stimulation (TENS) treatment. Method for Outcome Verification: Verified using the Numeric Pain Scale (NPS), both at rest and during the movement of raising arms to 90 degrees. Parameters Used for Outcome Verification: A reduction of at least 1 point in pain intensity after the intervention is considered clinically important;Expected Outcome 3: Assessment of respiratory muscle strength (Maximum Inspiratory Pressure - MIP and Maximum Expiratory Pressure - MEP) before surgery, before Transcutaneous Electrical Nerve Stimulation (TENS) intervention, immediately after TENS intervention, and 1 hour after TENS treatment. Method for Outcome Verification: Measurement using an analog manovacuometer (MA) with an operational range of 300 cmH2O. Parameters Used for Outcome Verification: The highest values, not exceeding 10% of the second-highest value, will be considered for data analysis;Expected Outcome 4: Assessment of the cutaneous sensitivity threshold in the breasts before, immediately after, and one hour after Transcutaneous Electrical Nerve Stimulation (TENS) intervention. Method for Outcome Verification: Utilization of a Semmes-Weinstein pressure aesthesiometer (Sorri®, Bauru, SP, Brazil) and Von Frey filaments test to evaluate pa | — |
Countries
Brazil
Contacts
Public ContactKamylla Santos
Universidade Federal de São Carlos (UFSCar)
Outcome results
None listed