Use of Electroanalgesia in Pain and Pulmonary Function.

Study Overview
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Brief Summary
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It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

Detailed Description
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This is an uncontrolled cross-sectional clinical trial with a sample of 66 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes. Through this research, it is expected that the patients who perform TENS present a reduction in postoperative pain and, consequently, a lower impact on lung function.

Official Title
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Role of Transcutaneous Electrical Nerve Stimulation in Pain Relief and Pulmonary Function in Patients Undergoing Bariatric Surgery

Conditions
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Bariatric Surgery, Obesity, Morbid

Intervention / Treatment
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* Other: Experimental: Electroanalgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over Exclusion Criteria: Patients over the age of 50; Individuals who present hemodynamic instability in the postoperative period; Use of mechanical ventilation for more than 24 hours; Contraindications regarding the use of TENS (presence of a cardiac pacemaker, hypersensitivity regarding the use of TENS); Previous history of epilepsy; Pregnant women during the first trimester; Patients with a score, on the Glasgow coma scale (Appendix I), less than 15; Patients who choose to withdraw during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an uncontrolled cross-sectional clinical trial with a sample of 132 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Electroanalgesia<br>The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia | |
| Experimental: Electroanalgesia<br>The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia | Other: Experimental: Electroanalgesia<br>* The sample will consist of 66 individuals, of both men and women, where they will be randomly included in two groups: Intervention group composed of 33 patients who will effectively receive the treatment through electroanalgesia via TENS;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| As a primary endpoint, pain using the visual analog pain scale. | This scale is considered valid to predict the level of pain in the postoperative period of bariatric surgery. The value being zero without pain and ten maximum pain. | 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in the strength of respiratory muscles, using manovacuometry. | The change in manovacuometry can reduce surgical complications. | 5 days. | 
| To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry. | The change in lung function can reduce surgical complications. | 5 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirometry, Electroanalgesia, Bariatric Surgery