Use of Electroanalgesia in Pain and Pulmonary Function.

March 13, 2021 updated by: Centro Universitário Augusto Motta

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio De Janeiro, RJ, Brazil, 21041-020
        • Recruiting
        • Centro Universitário Augusto Motta
        • Contact:
        • Sub-Investigator:
          • Cesar A Luchesa, Msc
        • Principal Investigator:
          • Agnaldo J Lopes, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Electroanalgesia
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
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
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
As a primary endpoint, pain using the visual analog pain scale.
Time Frame: 5 days.
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.
Time Frame: 5 days.
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.
Time Frame: 5 days.
The change in lung function can reduce surgical complications.
5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário Augusto Motta

Investigators

  • Principal Investigator: Cesar A Luchesa, MSc, Centro Universitário FAG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11613219.0.0000.5219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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