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Clinical Trial Summary

To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain, should be reduced as soon and as effectively as possible. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest


Clinical Trial Description

Annually, more than 200 million people undergo surgery worldwide and the number is increasing.To ensure early mobilization, minimize suffering, and to prevent postoperative complications and subsequent mortality, postoperative pain, should be reduced as soon and as effectively as possible. Acute complications include impaired mobility, respiratory difficulties, pneumonia, protracted healing processes, thromboembolic events like deep vein thrombosis or pulmonary embolism, and prolonged need for care . Acute postoperative pain also has several negative long-term effects gas, risk of residual pain, higher mortality risk and worsened patient outcome at 6 months especially in hip fractures of older individuals. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids .TENS is a non-invasive method that delivers electrical impulses through electrodes placed on the skin and has been shown to be an effective supplement that can decrease postoperative pain after thoracic and abdominal surgery . However, it is yet unclear whether TENS after orthopedic hip prosthesis surgery can reduce post-operative pain to improve early mobilization, decrease opioid consumption and shorten hospitalization time. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest. The primary aim of this feasibility study using a CE-marked TENS device with applied textile electrodes in a pair of pants is to reduce postoperative pain during mobilization following hip prosthesis surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05678101
Study type Interventional
Source Karolinska University Hospital
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 1, 2022
Completion date December 30, 2025

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