Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia
NCT ID: NCT03992820
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
8 participants
INTERVENTIONAL
2019-07-01
2020-03-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Results will be analysed based on the pain score records at the end of the trial
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The trial group will have the TENS to the area planned for injection for 30 minutes before injection of the local anaesthetic (a combination of 0.25% levobupivacaine and 1% lignocaine with 1/200,000 adrenaline). The control group will have EMLA applied on the site planned for local anaesthetic injection and after 1 hour , will be removed and immediately injected with the same anaesthetic solution (this is already a procedure practised by some of the surgeons).
Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration. The Numeric pain scale is filled in by the doctor as indicated by the patient. Pulse rate and Blood Pressure monitoring will be carried out as an objective measurement of response to pain (these are routinely recorded when patient is in the theater for a procedure). Patient involvement in the study ends at this point.
Analysis of the outcome will be done at the end of the trial period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
The website is http://www.randomizer.org The numbers generated will be placed in separate sealed envelopes by the department secretary and made available to the investigators.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TENS arm (trial arm)
The trial group will have the TENS (transcutaneous electrical nerve stimulator) to the area planned for injection for at least 30 minutes before injection of the local anaesthetic solution.
TENS machine
The trial group will have the TENS to the area planned for injection for at least 30 minutes before injection of the local anaesthetic solution.
Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration.
EMLA arm (Control arm)
The control group will have EMLA (Eutatic mixture of local anaesthetic) applied on the site planned for local anaesthetic injection and after 1 hour, will be removed and immediately injected with the same anaesthetic solution.
EMLA cream
The control group will have EMLA applied on the site planned for local anaesthetic injection and after 1 hour, will be removed and immediately injected with the same anaesthetic solution (this is already a procedure practised by many of the surgeons).
Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TENS machine
The trial group will have the TENS to the area planned for injection for at least 30 minutes before injection of the local anaesthetic solution.
Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration.
EMLA cream
The control group will have EMLA applied on the site planned for local anaesthetic injection and after 1 hour, will be removed and immediately injected with the same anaesthetic solution (this is already a procedure practised by many of the surgeons).
Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals, Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rajshree Jayarajan
Role: PRINCIPAL_INVESTIGATOR
University Hospitals, Leicester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals of Leicester
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kasat V, Gupta A, Ladda R, Kathariya M, Saluja H, Farooqui AA. Transcutaneous electric nerve stimulation (TENS) in dentistry- A review. J Clin Exp Dent. 2014 Dec 1;6(5):e562-8. doi: 10.4317/jced.51586. eCollection 2014 Dec.
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6.
Kalra A, Urban MO, Sluka KA. Blockade of opioid receptors in rostral ventral medulla prevents antihyperalgesia produced by transcutaneous electrical nerve stimulation (TENS). J Pharmacol Exp Ther. 2001 Jul;298(1):257-63.
Wall PD, Sweet WH. Temporary abolition of pain in man. Science. 1967 Jan 6;155(3758):108-9. doi: 10.1126/science.155.3758.108.
Sluka KA, Bjordal JM, Marchand S, Rakel BA. What makes transcutaneous electrical nerve stimulation work? Making sense of the mixed results in the clinical literature. Phys Ther. 2013 Oct;93(10):1397-402. doi: 10.2522/ptj.20120281. Epub 2013 May 2.
Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
Varadharaja M, Udhya J, Srinivasan I, Sivakumar JS, Karthik RS, Manivanan M. Comparative clinical evaluation of transcutaneous electrical nerve stimulator over conventional local anesthesia in children seeking dental procedures: A clinical study. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S113-7. doi: 10.4103/0975-7406.137407.
teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.
11. Choudhari SR, Parikrama SJ, Gaurav VK et al. Efficacy of transcutaneous electronic nerve stimulation in alleviating pain during inferior alveolar nerve block injections in pediatric dentistry. International Journal of Pedodontic Rehabilitation. 2017;2(2): 69-72
Meechan JG, Gowans AJ, Welbury RR. The use of patient-controlled transcutaneous electronic nerve stimulation (TENS) to decrease the discomfort of regional anaesthesia in dentistry: a randomised controlled clinical trial. J Dent. 1998 Jul-Aug;26(5-6):417-20. doi: 10.1016/s0300-5712(97)00062-6.
Dhindsa A, Pandit IK, Srivastava N, Gugnani N. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: A clinical study. Contemp Clin Dent. 2011 Jan;2(1):27-30. doi: 10.4103/0976-237X.79305.
Burri H, Piguet V. UninTENSional pacemaker interactions with transcutaneous electrical nerve stimulation. Europace. 2009 Mar;11(3):283-4. doi: 10.1093/europace/eup008. No abstract available.
Keskin EA, Onur O, Keskin HL, Gumus II, Kafali H, Turhan N. Transcutaneous electrical nerve stimulation improves low back pain during pregnancy. Gynecol Obstet Invest. 2012;74(1):76-83. doi: 10.1159/000337720. Epub 2012 Jun 21.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
113691
Identifier Type: -
Identifier Source: org_study_id