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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03491072
• Other study ID #: FMASU R 12/2018
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2018
• Last updated: April 8, 2018
• Start date: February 20, 2018
• Est. completion date: July 2018

Study information

• Verified date: April 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Transcutaneous 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.

Drug:
• Fentanyl
Patients will receive IV fentanyl

Locations

Country	Name	City	State
Egypt	Randa Ali Shoukry	Cairo	Al-Nozha

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fentanyl consumption	Total dose of requested and received fentanyl.	during the procedure of ESWL