Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia

NCT03992820 | Terminated DMC

• 1 other identifier: 113691
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Donor Site Complication; Skin Graft

Keywords

TENS; local anaesthetic cream; skin graft donor site

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in blood pressure in response to injection of local anaesthetic

  10 minutes

• Changes in heart rate in response to injection of local anaesthetic

  10 minutes

Study Arms (2)

TENS arm (trial arm)

EXPERIMENTAL

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.

Device: TENS machine

EMLA arm (Control arm)

OTHER

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.

Combination Product: EMLA cream

Interventions

TENS machine DEVICE

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.

TENS arm (trial arm)

EMLA cream COMBINATION_PRODUCT

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.

EMLA arm (Control arm)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 90 years undergoing a split skin graft harvest under local anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Location

Related Publications (15)

• 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.

  PMID: 25674327 BACKGROUND

• 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.

  PMID: 5320816 BACKGROUND

• 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.

  PMID: 24334188 BACKGROUND

• 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.

  PMID: 10215661 BACKGROUND

• 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.

  PMID: 11408550 BACKGROUND

• 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.

  PMID: 6015561 BACKGROUND

• 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.

  PMID: 23641031 BACKGROUND

• 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.

  PMID: 12600800 BACKGROUND

• 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.

  PMID: 25210350 BACKGROUND

• 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.

  PMID: 8378157 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 9699431 BACKGROUND

• 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.

  PMID: 22114450 BACKGROUND

• 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.

  PMID: 19240107 BACKGROUND

• 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.

  PMID: 22722614 BACKGROUND

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Rajshree Jayarajan

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After obtaining informed consent patients will be randomised to two groups using codes generated by web-based randomisation system- Research Randomizer. This is a free resource for researchers. 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: June 20, 2019
• Study Start: July 1, 2019
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)