Effects of transcutaneous electrical nerve stimulation on acute postoperative pain after breast augmentation surgery: placebo-controlled, double-blind randomized clinical trial protocol.

Abstract

Abstract ● Background: Breast augmentation is a surgical procedure that may result in postoperative pain. The use of analgesics to relieve pain may produce adverse effects and delay recovery. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological approach that can relieve pain by activating nerve fibers. However, the effectiveness of TENS in breast augmentation has yet to be investigated. The aim of this study was to assess the effects of TENS on pain intensity immediately after breast augmentation. The results have the potential to advance scientific and technological knowledge in the treatment of acute postoperative pain, using accessible non-pharmacological interventions that can improve patients’ experiences. ● Methods: A placebo-controlled, double-blind randomized clinical trial will be conducted with 52 participants submitted to breast augmentation following a rapid 24-hour recovery. Participants will be randomly allocated to two groups: active TENS and placebo TENS. Each participant will undergo a TENS treatment session. The primary outcome will be pain intensity assessed at rest and during movement, before and immediately after TENS. Secondary outcomes will include pain intensity one hour after treatment, respiratory muscle strength, satisfaction with the intervention and analgesic use in the first four hours after surgery. ● Discussion: The results of this study will provide important information on the effects of TENS in patients submitted to breast augmentation, contributing to improving ´postoperative pain. It is hoped that the findings of a non-pharmacological approach will contribute to developing more effective and less costly pain management strategies. This may result in a significant improvement in the experience of patients submitted to this surgical procedure. ● Trial registration: This study was prospectively registered in the Brazilian Clinical Trials Registry (ReBEC) on 01/02/2024 under registration number RBR-96h3k97.