NCT03491072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

March 31, 2018

Last Update Submit

April 8, 2018

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fentanyl consumption

    during the procedure of ESWL

Study Arms (2)

Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

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 stimulationDrug: Fentanyl

Fentanyl

ACTIVE COMPARATOR

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

Interventions

Transcutaneous electrical nerve stimulationDEVICE

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.

Also known as: TENS
Transcutaneous electrical nerve stimulation (TENS)
FentanylDRUG

Patients will receive IV fentanyl

Also known as: Fentanyl ampule for intravenous injection
FentanylTranscutaneous electrical nerve stimulation (TENS)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Randa Ali Shoukry

Cairo, Al-Nozha, 11843, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve StimulationFentanylInjections, Intravenous

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdministration, IntravenousDrug Administration RoutesDrug TherapyInjections

Study Officials

  • Randa AS Ahmed, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2018

First Posted

April 9, 2018

Study Start

February 20, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

EG(1)