Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03491072
Enrollment
60
Registered
2018-04-09
Start date
2018-02-20
Completion date
2018-07-31
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

extracorporeal shock-wave Lithotripsy,, pain relief during extracorporeal shock-wave Lithotripsy, fentanyl, Transcutaneous electrical nerve stimulation

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.

Interventions

DEVICETranscutaneous electrical nerve stimulation

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.

DRUGFentanyl

Patients will receive IV fentanyl

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity measure using visual analogue scale10 minutespatients will be instructed to mark the line with a pencil (0 = no pain 10= worst pain).

Secondary

MeasureTime frameDescription
Fentanyl consumptionduring the procedure of ESWLTotal dose of requested and received fentanyl.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026