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Use of Electroanalgesia in Pain and Pulmonary Function.

C

Centro Universitário Augusto Motta

Status

Unknown

Conditions

Bariatric Surgery
Obesity, Morbid

Treatments

Other: Experimental: Electroanalgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04800640
11613219.0.0000.5219

Details and patient eligibility

About

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.

Full description

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.

Enrollment

132 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 2 patient groups

No Electroanalgesia
No Intervention group
Description:
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
Electroanalgesia
Experimental group
Description:
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
Treatment:
Other: Experimental: Electroanalgesia

Trial contacts and locations

1

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Central trial contact

Cesar A Luchesa, MSc; Agnaldo J Lopes, PHd

Data sourced from clinicaltrials.gov

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