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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491072
Recruitment Status : Active, not recruiting
First Posted : April 9, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Randa Ali Shoukry, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Pain Device: Transcutaneous electrical nerve stimulation Drug: Fentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcutaneous Electric Nerve Stimulation (TENS) for Pain Relief During Extracorporeal Shock-wave Lithotripsy (ESWL)
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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 Name: TENS

Drug: Fentanyl
Patients will receive IV fentanyl
Other Name: 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 Name: Fentanyl ampule for intravenous injection




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Fentanyl consumption [ Time Frame: during the procedure of ESWL ]
    Total dose of requested and received fentanyl.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491072


Locations
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Egypt
Randa Ali Shoukry
Cairo, Al-Nozha, Egypt, 11843
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Randa AS Ahmed, MD Ain Shams University

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Responsible Party: Randa Ali Shoukry, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03491072    
Other Study ID Numbers: FMASU R 12/2018
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Randa Ali Shoukry, Ain Shams University:
extracorporeal shock-wave Lithotripsy,
pain relief during extracorporeal shock-wave Lithotripsy
fentanyl
Transcutaneous electrical nerve stimulation
Additional relevant MeSH terms:
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Shock
Pathologic Processes
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics