Transcutaneous Electric Nerve Stimulation for Pain Relief During Extracorporeal Shock-wave Lithotripsy

Study Overview
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Brief Summary
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This study evaluates pain relief during extracorporeal shock-wave Lithotripsy by using transcutaneous electrical nerve stimulation (TENS) and comparing it with fentanyl which is a narcotic analgesic. Half of the participants will receive a primary fentanyl dose together with TENS application, another half will receive a primary fentanyl dose. All patients will receive fentanyl increments if they still complained of pain.

Detailed Description
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The ideal anesthesia technique for ESWL must provide good analgesia, sufficient sedation, and rapid recovery with minimal side effects. Opioids are commonly used analgesics during ESWL. Fentanyl is a potent synthetic narcotic, which has rapid onset and a short duration of action, it offers an acceptable analgesia during ESWL but has a noticeable respiratory depression. Transcutaneous electrical nerve stimulation (TENS) is a method in which low voltage electrical impulses transmit through electrodes attached to the skin over a painful area. It is usually used to relieve a variety of painful conditions. A TENS unit contains electrical signal generator, a battery in addition to a set of electrodes. The TENS is small, programmable and the generator can deliver stimuli with different current intensities, pulse rates and pulse width. The mechanism of analgesia by TENS has been explained by many theories. the gate control theory by Melzack and Wall, stated that when an electrical current is applied to a painful area, transmission of pain through small diameter fibers is inhibited by the activity of the large diameter, fast-conducting proprioceptive sensory fibers, closing the gate to the pain perception to the brain. Another mechanism suggested is activation of descending inhibitory pathway, via release of endogenous opioids.

Official Title
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Transcutaneous Electric Nerve Stimulation (TENS) for Pain Relief During Extracorporeal Shock-wave Lithotripsy (ESWL)

Conditions
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Pain

Intervention / Treatment
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* Device: Transcutaneous electrical nerve stimulation
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for extracorporeal shock-wave Lithotripsy (ESWL), having a solitary renal stone 6 - 15 mm. Age18 to 75 years old. ASA physical status I -II. BMI of 25- 30. Exclusion Criteria: Patients with bleeding and coagulation disorder. Hypertension. Pregnancy, Patient with demand pacemaker. Dermatological lesions at the site of ESWL e.g. eczema or dermatitis. Drug or alcohol addiction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical nerve stimulation (TENS)<br>Patients will receive IV fentanyl 1µg /Kg with the application of conventional TENS in which constant mode will be chosen. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl. | Device: Transcutaneous electrical nerve stimulation<br>* Patients will receive IV fentanyl 1µg /Kg with the application of conventional TENS in which constant mode will be chosen. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl.<br>* Other names: TENS;Drug: Fentanyl<br>* Patients will receive IV fentanyl<br>* Other names: Fentanyl ampule for intravenous injection;|
| Active Comparator: Fentanyl<br>Patients will receive IV fentanyl 1µg /Kg. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl. | Drug: Fentanyl<br>* Patients will receive IV fentanyl<br>* Other names: Fentanyl ampule for intravenous injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measure using visual analogue scale | patients will be instructed to mark the line with a pencil (0 = no pain 10= worst pain). | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption | Total dose of requested and received fentanyl. | during the procedure of ESWL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, extracorporeal shock-wave Lithotripsy,, pain relief during extracorporeal shock-wave Lithotripsy, Transcutaneous electrical nerve stimulation