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Use of Electroanalgesia in Pain and Pulmonary Function.

Primary Purpose

Bariatric Surgery, Obesity, Morbid

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental: Electroanalgesia
Sponsored by
Centro Universitário Augusto Motta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery focused on measuring Spirometry, Electroanalgesia, Bariatric Surgery

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Centro universitário augusto mottaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Electroanalgesia

Electroanalgesia

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate changes in the strength of respiratory muscles, using manovacuometry.
The change in manovacuometry can reduce surgical complications.
To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry.
The change in lung function can reduce surgical complications.

Full Information

First Posted
March 23, 2020
Last Updated
March 13, 2021
Sponsor
Centro Universitário Augusto Motta
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1. Study Identification

Unique Protocol Identification Number
NCT04800640
Brief Title
Use of Electroanalgesia in Pain and Pulmonary Function.
Official Title
Role of Transcutaneous Electrical Nerve Stimulation in Pain Relief and Pulmonary Function in Patients Undergoing Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Universitário Augusto Motta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Obesity, Morbid
Keywords
Spirometry, Electroanalgesia, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
He sample will consist of 132 individuals, of both men and women, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia via TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia. For division of groups, a sortition will be carried out through envelopes where it will be decided to which study group the patient will be allocated.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Electroanalgesia
Arm Type
No Intervention
Arm 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
Arm Title
Electroanalgesia
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Experimental: Electroanalgesia
Intervention Description
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;
Primary Outcome Measure Information:
Title
As a primary endpoint, pain using the visual analog pain scale.
Description
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.
Time Frame
5 days.
Secondary Outcome Measure Information:
Title
Evaluate changes in the strength of respiratory muscles, using manovacuometry.
Description
The change in manovacuometry can reduce surgical complications.
Time Frame
5 days.
Title
To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry.
Description
The change in lung function can reduce surgical complications.
Time Frame
5 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar A Luchesa, MSc
Phone
55 (45) 984228189
Email
fisioterapia_ala@saolucas.fag.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Agnaldo J Lopes, PHd
Phone
55 (21) 99853-6162
Email
agnaldolopes.uerj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar A Luchesa, MSc
Organizational Affiliation
Centro Universitário FAG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro universitário augusto motta
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
21041-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnaldo J Lopes, PHD
Phone
(21)38829797
Ext
2012
Email
agnaldolopes.uerj@gmail.com
First Name & Middle Initial & Last Name & Degree
Cesar A Luchesa, Msc
First Name & Middle Initial & Last Name & Degree
Agnaldo J Lopes, Phd

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9066400
Citation
Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. doi: 10.1016/s0003-4975(96)01249-0.
Results Reference
background
PubMed Identifier
12600800
Citation
Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
Results Reference
background
PubMed Identifier
18417519
Citation
Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.
Results Reference
background
PubMed Identifier
16331341
Citation
Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.
Results Reference
background
PubMed Identifier
35692935
Citation
Luchesa CA, Lopes AJ. Role of Transcutaneous Electric Nerve Stimulation in Pain and Pulmonary Function in Patients after Bariatric Surgery. Rehabil Res Pract. 2022 Jun 2;2022:9138602. doi: 10.1155/2022/9138602. eCollection 2022.
Results Reference
derived

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Use of Electroanalgesia in Pain and Pulmonary Function.

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