Postoperative Pain Clinical Trial
Official title:
Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery: Randomized Clinical Trial.
NCT number | NCT04964973 |
Other study ID # | CEIC 15012 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | March 8, 2022 |
Verified date | November 2022 |
Source | University of Las Palmas de Gran Canaria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chest pain is one of the most difficult problems to solve after thoracic surgery. Its correct control is often quite difficult, which can cause complications due to an ineffective cough and superficial respiratory movements. It could provoke secretion retention, lung atelectasis, and even pneumonia. In addition, insufficient treatment of postoperative pain also causes a slower recovery of mobility, delaying the incorporation to daily life activities. Transcutaneous electrical stimulation (TENS) is a technique that attempts to establish pain control by applying electrical current through superficial electrodes Is transcutaneous electrical nerve stimulation effective for the pain rehabilitation approach after thoracic surgery? Are there spirometry changes related to pulmonary function after the application of transcutaneous electrical nerve stimulation in postoperative rehabilitation of thoracic surgical patients?
Status | Completed |
Enrollment | 111 |
Est. completion date | March 8, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Signed the informed consent. - Affected by pulmonary or mediastinal pathology. - Who have required thoracic surgery. Exclusion Criteria: - Patients with pacemakers. - Diseases with chronic need for analgesic drug. - History of drug addiction. - Patients who do not require hospital readmission after surgery. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital of Gran Canaria Dr. Negrín | Las Palmas De Gran Canaria | Las Palmas |
Lead Sponsor | Collaborator |
---|---|
University of Las Palmas de Gran Canaria |
Spain,
Fiorelli A, Morgillo F, Milione R, Pace MC, Passavanti MB, Laperuta P, Aurilio C, Santini M. Control of post-thoracotomy pain by transcutaneous electrical nerve stimulation: effect on serum cytokine levels, visual analogue scale, pulmonary function and medication. Eur J Cardiothorac Surg. 2012 Apr;41(4):861-8; discussion 868. doi: 10.1093/ejcts/ezr108. Epub 2011 Dec 16. — View Citation
Husch HH, Watte G, Zanon M, Pacini GS, Birriel D, Carvalho PL, Kessler A, Sbruzzi G. Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pulmonary Function, and Respiratory Muscle Strength After Posterolateral Thoracotomy: A Randomized Controlled Trial. Lung. 2020 Apr;198(2):345-353. doi: 10.1007/s00408-020-00335-4. Epub 2020 Feb 8. — View Citation
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available. — View Citation
Solak O, Turna A, Pekcolaklar A, Metin M, Sayar A, Solak O, Gürses A. Transcutaneous electric nerve stimulation for the treatment of postthoracotomy pain: a randomized prospective study. Thorac Cardiovasc Surg. 2007 Apr;55(3):182-5. — View Citation
Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spirometry | It will consist of a simple spirometry using the Datospir Micro Sibelmed spirometer. The values of the forced vital capacity (FVC) and the volume expired forged in the first second (FEV1) are shown in percentages according to the theoretical values | Six month | |
Primary | McGill Test | A McGill test will be performed to analyze the level of immediate postoperative pain. The McGill test (Painting Classification Index) (PRI) measures three dimensions: sensory, affective, and evaluative. It consists of 66 words (pain descriptors). | Six month | |
Primary | Quality of life survey sf-36 | The SF-36 Questionnaire is one of the most used and evaluated Health-Related Quality of Life (HRQOL) instruments. | Six month |
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