Transcutaneous Electrical Nerve Stimulation Post-thoracic Surgery in a Intensive Care Unit

NCT02438241 | Unknown Phase 1 DMC

• 1 other identifier: 36851514.6.0000.5335
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Pain is an important factor of increase of morbidity and mortality in patients undergoing surgical procedures include thoracotomy. There are different methods of analgesia in postoperative thoracic surgery, ranging from systemic analgesia with opioids, as well as local anesthetics block (intrapleural, extrapleural, intercostal cryoanalgesia, etc.) in addition to spinal blocks and Epidural blocks. In the pharmacological analgesia, electroanalgesia has been proposed as an adjunctive treatment for the relief of postoperative pain. Rationale: noting the lack of data in the literature regarding the use of this physical therapy technique in order to reduce the pain in the postoperative period of thoracic surgery and its consequences, it is relevant to the realization of a new randomized controlled trial (RCT) to evaluate the effects of transcutaneous electrical nerve (TENS) in the post - thoracic surgery on pain, pulmonary function and strength respiratory muscle. Objective: To evaluate the effects of TENS on pain, respiratory muscle strength and lung function in postoperative thoracic surgery in a Intensive Care Unit. Method: The subjects included will be randomized into three groups randomly: control group (CG) that will hold only conventional physical therapy, TENS group (EG) that will hold the application of TENS associated with conventional physical therapy, TENS placebo group (GP) who will perform the application of TENS placebo to conventional therapy. All groups carry out the assessments (digital manometer, spirometry, visual analog pain scale) in the preoperative period, postoperative Immediate / pre-intervention and at the end of treatment (discharge from the intensive care unit), except for the pain that will be evaluated before and after each intervention session. All patients receive physical therapy three times a day (morning, afternoon and evening) during hospitalization in the intensive care unit. Intervention: The conventional group will receive conventional therapy for hospital service. The TENS group will receive conventional therapy and the end of that service, will be applied TENS for 30 minutes. The placebo TENS group will receive the conventional physical therapy and the end of the service will be installed TENS placebo, during this period the patient receives electrical stimulation for 45 seconds, shutting down at the end of this time and held position as TENS group.

Conditions

Thoracic Surgery

Keywords

Pain Measurement; Electric Stimulation; Spirometry; Manometry

Outcome Measures

Primary Outcomes (1)

• Assess the pain of change in postoperative thoracic surgery

  It will be used a visual analogous scale to assess pain after each service physiotherapy

  3 days

Study Arms (3)

Conventional physiotherapy Group

ACTIVE COMPARATOR

Patients randomized to this group will receive only conventional physiotherapy. The treatment protocol will consist of weathered active exercises to manually lower limbs in bed (triple flexion, abduction and adduction, plantar / dorsiflexion), free active exercises of the upper limbs in the bed (shoulder flexion, shoulder flexion and horizontal functional diagonal shoulder), bronchial hygiene techniques, flow redirection, positive expiratory pressure and ventilatory blowing patterns.

Procedure: Conventional physiotherapy Group

Placebo TENS Group

PLACEBO COMPARATOR

Will be held the same procedure as TENS group, except that TENS will be offered to the patient only for 45 seconds, and in the first 30 seconds is reached the sensory threshold of the patient and in the last 15 seconds will turn off the electrical current by 29 remaining period minutes and 15 seconds off.

Procedure: Placebo TENS group

TENS group

EXPERIMENTAL

Patients randomized to this group will receive conventional physical therapy for the control group, and the end of that service, will be applied TENS. TENS is accomplished through the use of an electrical stimulation device with symmetrical biphasic current pulse. The following parameters are used: frequency: 100 Hz, pulse width: 100 µs, intensity to the greatest sensory threshold of the patient and total session time: 30 minutes. Self-adhesive electrodes will be used (Valutrode, size 5x9 cm) to be positioned in the posterolateral portion of the chest to 2 cm skin incision both upper and lower.

Procedure: TENS Group

Interventions

Conventional physiotherapy Group PROCEDURE

Patients randomized to this group will receive only conventional physiotherapy. The treatment protocol Control Group, will consist of weathered active exercises to manually lower limbs in bed (triple flexion, abduction and adduction, plantar / dorsiflexion), free active exercises of the upper limbs in the bed (shoulder flexion, shoulder flexion and horizontal functional diagonal shoulder), bronchial hygiene techniques, flow redirection, positive expiratory pressure and ventilatory blowing patterns.

Conventional physiotherapy Group

TENS Group PROCEDURE

Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), and the end of that service, will be applied TENS. TENS is accomplished through the use of an electrical stimulation device with symmetrical biphasic current pulse. The following parameters are used: frequency: 100 Hz, pulse width: 100 µs, intensity to the greatest sensory threshold of the patient and total session time: 30 minutes. Self-adhesive electrodes will be used (Valutrode, size 5x9 cm) to be positioned in the posterolateral portion of the chest to 2 cm skin incision both upper and lower.

TENS group

Placebo TENS group PROCEDURE

Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), will be held the same procedure as TENS group, except that TENS will be offered to the patient only for 45 seconds, and in the first 30 seconds is reached the sensory threshold of the patient and in the last 15 seconds will turn off the electrical current by 29 remaining period minutes and 15 seconds off.

Placebo TENS Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Will be included patients between 30 and 75 years;
• Both sexes;
• Post-thoracic surgery with posterolateral thoracotomy incision for pulmonary resection (Bullectomy, segmentectomy, lobectomy, pneumonectomy);
• Evaluated between 4-6 hours after entry into the intensive care unit;
• Hemodynamic stability (mean arterial pressure between 60 mmHg and 100 mmHg, heart rate between 50 bpm and 110 bpm, peripheral saturation greater than 90%);
• Patients who have liquid drainage chest tubes in less than 300 ml for six hours;
• Scale agitation-sedation Richmond (RASS) between -1 and +1;
• Prescription physical therapy;
• Have epidural or Paravertebral catheter;
• Agree to participate in the study by signing the Informed Consent and Informed (IC ).

You may not qualify if:

• Not intubated with up to 6 hours in the immediate postoperative period;
• Primary pulmonary disease not rise (cardiovascular, neurological diseases);
• Hemodynamic instability (with pressure mean blood less than 60 mmHg or greater 100 mmHg, heart rate less than 49 bpm and greater than 111 bpm, reduced peripheral saturation of 90%);
• Patients who have the upper drainage liquid drains to 300 ml for six hours;
• Scale agitation-sedation Richmond (RASS) between -5 and -2, and agitated / aggressive patients, scale agitation-sedation Richmond RASS +2 and +4;
• Prescribing physical therapy;
• Without epidural or paravertebral catheter;
• Patients who do not accept the study, not collaborative and do not sign the informed consent form.

Sponsors & Collaborators

• Irmandade Santa Casa de Misericórdia de Porto Alegre: lead

Study Sites (1)

Irmandade Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Related Publications (14)

• Landreneau RJ, Pigula F, Luketich JD, Keenan RJ, Bartley S, Fetterman LS, Bowers CM, Weyant RJ, Ferson PF. Acute and chronic morbidity differences between muscle-sparing and standard lateral thoracotomies. J Thorac Cardiovasc Surg. 1996 Nov;112(5):1346-50; discussion 1350-1. doi: 10.1016/S0022-5223(96)70150-2.

  PMID: 8911333 RESULT

• Savage C, McQuitty C, Wang D, Zwischenberger JB. Postthoracotomy pain management. Chest Surg Clin N Am. 2002 May;12(2):251-63. doi: 10.1016/s1052-3359(02)00011-x.

  PMID: 12122825 RESULT

• Kavanagh BP, Katz J, Sandler AN. Pain control after thoracic surgery. A review of current techniques. Anesthesiology. 1994 Sep;81(3):737-59. doi: 10.1097/00000542-199409000-00028. No abstract available.

  PMID: 8092520 RESULT

• Boisseau N, Rabary O, Padovani B, Staccini P, Mouroux J, Grimaud D, Raucoules-Aime M. Improvement of 'dynamic analgesia' does not decrease atelectasis after thoracotomy. Br J Anaesth. 2001 Oct;87(4):564-9. doi: 10.1093/bja/87.4.564.

  PMID: 11878725 RESULT

• 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.

  PMID: 9066400 RESULT

• Yegin A, Erdogan A, Kayacan N, Karsli B. Early postoperative pain management after thoracic surgery; pre- and postoperative versus postoperative epidural analgesia: a randomised study. Eur J Cardiothorac Surg. 2003 Sep;24(3):420-4. doi: 10.1016/s1010-7940(03)00345-2.

  PMID: 12965314 RESULT

• Grant RP. Con: every postthoracotomy patient does not deserve thoracic epidural analgesia. J Cardiothorac Vasc Anesth. 1999 Jun;13(3):355-7. doi: 10.1016/s1053-0770(99)90277-x. No abstract available.

  PMID: 10392691 RESULT

• Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.

  PMID: 24488821 RESULT

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 RESULT

• Chandra A, Banavaliker JN, Das PK, Hasti S. Use of transcutaneous electrical nerve stimulation as an adjunctive to epidural analgesia in the management of acute thoracotomy pain. Indian J Anaesth. 2010 Mar;54(2):116-20. doi: 10.4103/0019-5049.63648.

  PMID: 20661348 RESULT

• 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.

  PMID: 16331341 RESULT

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 RESULT

• Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.

  PMID: 10412550 RESULT

• Husch HH, Watte G, Zanon M, Pacini GS, Birriel D, Carvalho PL, Kessler A, Sbruzzi G. Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pulmonary Function, and Respiratory Muscle Strength After Posterolateral Thoracotomy: A Randomized Controlled Trial. Lung. 2020 Apr;198(2):345-353. doi: 10.1007/s00408-020-00335-4. Epub 2020 Feb 8.

  PMID: 32036406 DERIVED

Related Links

• Estimulação elétrica nervosa transcutânea no pós-operatório de cirurgia torácica: revisão sistemática e metanálise de estudos randomizados

Study Officials

• Graciele Sbruzzi, doctor

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist intensive care unit

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 12, 2015

Record last verified: 2014-12

Locations

BR (1)