Postoperative Pain
Conditions
Interventions
This is a triple-blind, two-arm, randomized controlled clinical trial with 28 participants, 14 allocated to the intervention group and 14 to the control group. The randomization sequence will be gener
s tolerance, ranging from 13.79 to 39.93 mA, and a total application time of 30 minutes per session. A four-channel transcutaneous electrical nerve stimulation clinical device duly registered with the
Sponsors
Hospital de Reabilitação de Anomalias Craniofaciais da Universidade de São Paulo
Hospital de Reabilitação de Anomalias Craniofaciais da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients presenting with unilateral (left or right side) or bilateral cleft lip and palate. Who are candidates for and eligible for bimaxillary orthognathic surgery. Patients aged 18 years or older. Both sexes
Exclusion criteria
Exclusion criteria: Patients with syndromes. Individuals who have previously undergone orthognathic surgery. Patients with rare facial clefts. Patients with cardiac pacemakers or other implantable electronic devices. History of uncontrolled epilepsy. Pregnant women. Presence of neoplasms in the area of ??application of Transcutaneous Electrical Nerve Stimulation - TENS. Presence of skin lesions, local infection, areas with altered sensitivity, or any condition that prevents proper electrode placement. Hypersensitivity or intolerance to electrical stimulation. Patients with previous chronic craniofacial pain (such as migraine, trigeminal neuralgia, chronic headaches, post-herpetic neuralgia, fibromyalgia, or other chronic pain syndromes). Patients who have contraindications to the standardized postoperative medication protocol (Sodium Dipyrone and Dexamethasone), such as hypersensitivity, decompensated diabetes mellitus, or other clinical conditions that prevent its administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study aims to evaluate the intensity of postoperative pain in patients with cleft lip and palate undergoing orthognathic surgery, using the visual analog scale, at 6, 24, and 48 hours after the procedure. A reduction in pain scores was observed in the group undergoing transcutaneous electrical nerve stimulation compared to the control group, based on the analysis of differences between the mean values ??of the visual analog scale between the groups over the evaluated periods, considering an estimated difference of 0.7 points between the means, a standard deviation of 0.63, an effect size of 1.11, and a significance level of 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study aims to evaluate the consumption of rescue analgesics in the postoperative period in patients with cleft lip and palate undergoing orthognathic surgery, by quantifying the total amount administered in milligrams and the number of doses used in the first 48 hours after the procedure. A reduction in analgesic consumption was observed in the group undergoing transcutaneous electrical nerve stimulation compared to the control group, based on the analysis of the differences between the total values ??and the number of doses between the groups.;The study aims to evaluate the variation in pain intensity before and after the application of transcutaneous electrical nerve stimulation in patients with cleft lip and palate undergoing orthognathic surgery, using the visual analog scale, at 6, 24, and 48 hours after the procedure. A reduction in pain scores was observed after the intervention in the group undergoing transcutaneous electrical nerve stimulation, based on the analysis of the differences between the values ??obtained before and immediately after each application, considering a significance level of 5%. | — |
Countries
BR
Contacts
Public ContactGustavo Ferreira
Hospital de Reabilitação de Anomalias Craniofaciais - HRAC/USP.
Outcome results
None listed