TerminatedNot Applicable

Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia

Stopped: Stopped early due to COVID19 restrictions

United Kingdom8 participantsStarted 2019-07-01

Plain-language summary

TENS-LA trial is a randomised control trial to assess the possible efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) on eliminating or reducing the pain of local anaesthetic injection for minor surgical procedures. Comparison is done with a mixture of local anaesthetic cream (EMLA) which is used at times for the same purpose. Though local procedures are carried out in various parts of the body, this trial will be conducted specifically on patients undergoing a split skin graft harvest from the thigh. Patients who meet the eligibility criteria and are willing to participate will be randomised to receive either TENS or EMLA. Results will be analysed based on the pain score records at the end of the trial

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Both interventions will be carried out in adult patients. For the purpose of standardisation and avoiding the variations from different sites in the body, and different surgical procedures, the site will be the thigh in both groups which is the donor site for a split skin graft. Inclusion criteria: • Adult patients aged 18 to 90 years undergoing a split skin graft harvest under local anaesthesia Exclusion criteria: * Patients below 18 and above 90 years of age * Patients with dementia or other mental abnormalities causing incapacity. * Pregnant ladies * Patients with pace maker or ICD * Patients with history of epilepsy or aneurysm * Patients with undiagnosed skin or pain conditions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome is pain of local anaesthetic injection after application of TENS or LA cream as measured by two Numeric Pain Rating Scale

Timeframe: 10 minutes

Trial details

NCT IDNCT03992820

SponsorUniversity Hospitals, Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-18

View on ClinicalTrials.gov More Donor Site Complication trials