search
Back to results

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

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Fentanyl
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring extracorporeal shock-wave Lithotripsy,, pain relief during extracorporeal shock-wave Lithotripsy, fentanyl, Transcutaneous electrical nerve stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Randa Ali Shoukry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcutaneous electrical nerve stimulation (TENS)

Fentanyl

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fentanyl consumption
Total dose of requested and received fentanyl.

Full Information

First Posted
March 31, 2018
Last Updated
April 8, 2018
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT03491072
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
extracorporeal shock-wave Lithotripsy,, pain relief during extracorporeal shock-wave Lithotripsy, fentanyl, Transcutaneous electrical nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous electrical nerve stimulation (TENS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanyl ampule for intravenous injection
Intervention Description
Patients will receive IV fentanyl
Primary Outcome Measure Information:
Title
Pain intensity measure using visual analogue scale
Description
patients will be instructed to mark the line with a pencil (0 = no pain 10= worst pain).
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Fentanyl consumption
Description
Total dose of requested and received fentanyl.
Time Frame
during the procedure of ESWL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa AS Ahmed, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Randa Ali Shoukry
City
Cairo
State/Province
Al-Nozha
ZIP/Postal Code
11843
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs