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

April 8, 2018 updated by: Randa Ali Shoukry, Ain Shams University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al-Nozha
      • Cairo, Al-Nozha, Egypt, 11843
        • Randa Ali Shoukry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous electrical nerve stimulation (TENS)
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
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.
Other Names:
  • TENS
Drug: Fentanyl
Patients will receive IV fentanyl
Other Names:
  • Fentanyl ampule for intravenous injection
Active Comparator: Fentanyl
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
Patients will receive IV fentanyl
Other Names:
  • Fentanyl ampule for intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measure using visual analogue scale
Time Frame: 10 minutes
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
Time Frame: during the procedure of ESWL
Total dose of requested and received fentanyl.
during the procedure of ESWL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Randa AS Ahmed, MD, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

March 31, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 8, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 12/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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