Clinical trial NCT04800640: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Obesity, Morbid
Keywords: Spirometry
Electroanalgesia
Bariatric Surgery
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: As a primary endpoint, pain using the visual analog pain scale.
timeFrame: 5 days.
Secondary outcomes:
measure: Evaluate changes in the strength of respiratory muscles, using manovacuometry.
timeFrame: 5 days.
measure: To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry.
timeFrame: 5 days.
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Centro universitário augusto motta
state: RJ
Study officials:
affiliation: Centro Universitário FAG
name: Cesar A Luchesa, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.