Transcutaneous Electrical Nerve Stimulation Post-thoracic Surgery in a Intensive Care Unit
NCT02438241 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2015-05-12
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
Interventions
- PROCEDURE
-
Conventional physiotherapy Group
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.
- PROCEDURE
-
TENS Group
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.
- PROCEDURE
-
Placebo TENS group
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.
Sponsors & Collaborators
-
Irmandade Santa Casa de Misericórdia de Porto Alegre
lead OTHER
Principal Investigators
-
Graciele Sbruzzi, doctor · Federal University of Rio Grande do Sul
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2015-12-31
- Completion
- 2016-06-30
Countries
- Brazil
Study Locations
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