Use of Electroanalgesia in Pain and Pulmonary Function.

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800640
• Other study ID #: 11613219.0.0000.5219
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2021
• Source: Centro Universitário Augusto Motta
• Contact: Cesar A Luchesa, MSc
• Phone: 55 (45) 984228189
• Email: fisioterapia_ala[@]saolucas.fag.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: October 30, 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity, Morbid

Intervention

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;

Locations

Country	Name	City	State
Brazil	Centro universitário augusto motta	Rio De Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate changes in the strength of respiratory muscles, using manovacuometry.	The change in manovacuometry can reduce surgical complications.	5 days.
Secondary	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.