PainNCT03491072
Transcutaneous Electric Nerve Stimulation for Pain Relief During Extracorporeal Shock-wave Lithotripsy
A study testing Transcutaneous electrical nerve stimulation and Fentanyl in people with Pain, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation and Fentanyl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2018to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called 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.
FentanylDrug
Also called Fentanyl ampule for intravenous injection
Patients will receive IV fentanyl
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous electrical nerve stimulation; Drug: 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measure using visual analogue scale
patients will be instructed to mark the line with a pencil (0 = no pain 10= worst pain).
Measured: 10 minutes
Secondary outcomes (1)
Fentanyl consumption
Total dose of requested and received fentanyl.
Measured: during the procedure of ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start20 Feb 2018
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Ali Shoukry, Ain Shams University
- Investigators
- Randa AS Ahmed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491072
- Sponsor's protocol ID
- FMASU R 12/2018
- Status last verified
- Apr 2018
- First submitted
- 31 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electric Nerve Stimulation (TENS) for Pain Relief During Extracorporeal Shock-wave Lithotripsy (ESWL)
- ClinicalTrials.gov ID
- NCT03491072
- Acronym / sponsor ID
- FMASU R 12/2018
- Conditions
- Pain
- Keywords
- extracorporeal shock-wave Lithotripsy,, pain relief during extracorporeal shock-wave Lithotripsy, fentanyl, Transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Device: Transcutaneous electrical nerve stimulation, Drug: FentanylPatients 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. |
| Fentanyl | Active comparator | Drug: FentanylPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with bleeding and coagulation disorder.
- Hypertension.
- Pregnancy,
- Patient with demand pacemaker.
- Dermatological lesions at the site of ESWL e.g. eczema or dermatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulationAlso: TENSPatients 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 (TENS) |
| FentanylAlso: Fentanyl ampule for intravenous injectionPatients will receive IV fentanyl | Drug | Fentanyl, Transcutaneous electrical nerve stimulation (TENS) |
Primary outcome
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).
1 secondary outcome
Fentanyl consumption
Time frame: during the procedure of ESWL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa AS Ahmed, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and Fentanyl in people with Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measure using visual analogue scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.