Clinical trial NCT05927168: Effect of TENS Application After Thoracic Surgery
Official title: Effect of TENS Application After Thoracic Surgery on Pain Level and Analgesic Consumption During Breast Tube Extraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Procedural Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After thoracic surgery, a chest tube is inserted to evacuate the air and fluid formed in the pleural space and to provide hemodynamic stability. During chest tube placement, subcutaneous tissue layers, muscles and parietal pleura are passed through. This process is a trauma and the affected tissues show an inflammatory reaction to the trauma. The chest tube adheres to the tissue it comes into contact with and may experience mild, moderate and severe pain due to the separation of the adhesion due to pulling during removal. Chest tube removal is described as a severely painful procedure in studies. Analgesics are generally used in the treatment of acute pain during chest tube removal (Wei et al. 2022). However, pain guidelines and studies recommend the use of analgesics with non-pharmacological methods in order to minimize the pain experienced during chest tube removal and to provide adequate analgesia. One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). TENS, an electroanalgesia method, helps to control pain by providing skin stimulation through surface electrodes placed on the skin.While there are studies in the literature on the use of TENS in reducing the pain caused by chest tube removal after different surgical interventions, there are limited studies investigating the effect of TENS on the level of pain during chest tube removal and postoperative analgesic consumption after thoracic surgery. In this context, in this study, it is aimed to determine the effect of TENS application after thoracic surgery on pain level and analgesic requirement during chest tube removal.

Detailed description: One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). Nurses play an important role in patient follow-up after surgery. It also has the responsibility to administer analgesics with the least side effects and the most effect. The New York Association of Nurses states that TENS is a complementary treatment method and its application strengthens the professional independence of nurses. However, as a result of our studies and observations, it is seen that there is no protocol for the use of TENS after thoracic surgery. TENS is applied together with physicians according to the nursing regulations in Turkey. Postoperative pain management requires team collaboration. Therefore, nurses should play a key role in pain management and use non-pharmacological methods.

Eligibility criteria: Inclusion Criteria:

* be over 18 years old
* no chest tube
* not have a pacemaker or arrhythmia
* no history of pain, alcohol use or substance abuse
* no prior pre-operative TENS/opioid use
* no postoperative epidural analgesics
* no history of psychiatric illness
* no history of metastatic disease
* being conscious, able to speak
* no barriers to the application of TENS
* no postoperative complications and being I, II and III in the ASA classification of the American Society of Anesthesiology.

Exclusion Criteria:

* having a history of epilepsy
* using analgesics at least 1 hour before chest tube removal.

Primary outcomes:
measure: Change in the pain level
timeFrame: 1 hour
measure: Change in analgesic consumption
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıcam
Study officials:
affiliation: Cukurova University
name: Açelya Türkmen, PhD
role: PRINCIPAL_INVESTIGATOR
References: