Clinical trial NCT03491072: Transcutaneous Electric Nerve Stimulation for Pain Relief During Extracorporeal Shock-wave Lithotripsy
Official title: Transcutaneous Electric Nerve Stimulation (TENS) for Pain Relief During Extracorporeal Shock-wave Lithotripsy (ESWL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: extracorporeal shock-wave Lithotripsy,
pain relief during extracorporeal shock-wave Lithotripsy
fentanyl
Transcutaneous electrical nerve stimulation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity measure using visual analogue scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Fentanyl consumption
timeFrame: during the procedure of ESWL
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Randa Ali Shoukry
state: Al-Nozha
Study officials:
affiliation: Ain Shams University
name: Randa AS Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: