Donor Site Complication Clinical Trial
— TENS-LAOfficial title:
The Efficacy of Transcutaneous Electrical Nerve Stimulation Versus Local Anaesthetic Cream in Alleviating the Pain of Local Anaesthetic Injections in Adults - A Randomised Controlled Trial
NCT number | NCT03992820 |
Other study ID # | 113691 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | March 18, 2020 |
Verified date | November 2023 |
Source | University Hospitals, Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 8 |
Est. completion date | March 18, 2020 |
Est. primary completion date | March 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals of Leicester | Leicester |
Lead Sponsor | Collaborator |
---|---|
University Hospitals, Leicester |
United Kingdom,
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
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is pain of local anaesthetic injection after application of TENS or LA cream as measured by two Numeric Pain Rating Scale | Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups. One scale will assess the pain caused by needle piercing the skin and the second will do so for the pain caused by infiltration of local anaesthetic agent.
The scale used is "Numeric Pain rating scale" which shows a transverse line with values from 0 to 10 from left to right where 0 indicates no pain and 10 worst possible pain. The middle, which is 5 indicates moderate pain. Outcome of the intervention is better towards the left indicating less pain and worse towards the right indicating more pain. No sub scales are used. |
10 minutes | |
Secondary | Changes in blood pressure in response to injection of local anaesthetic | Blood Pressure (BP) monitoring will be carried out as an objective measurement of response to pain. The unit of measurement is mm of Hg (millimetres of Mercury). This measurement is to assess if there is a rise in BP in response to the local anaesthetic injection after application of either TENS or EMLA and if present, to what extent. The changes will be analysed with respect to the baseline BP recording of the patient. | 10 minutes | |
Secondary | Changes in heart rate in response to injection of local anaesthetic | Heart rate (HR) monitoring will be carried out as an objective measurement of response to pain. The unit of measurement is number per minute. This measurement is to assess if there is a rise in HR in response to the local anaesthetic injection after application of either TENS or EMLA and if present, to what extent. The changes will be analysed with respect to the baseline HR recording of the patient. | 10 minutes |
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