Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia — TENS-LA  

Donor Site Complication Clinical Trial

Official 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

Status Terminated

Clinical Trial 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

Clinical Trial Description

Patients undergoing a split skin graft harvest will be selected from theatre lists and will be given complete information regarding the nature of trial, possible complications, risks and advantages by sending them a Patient Information Sheet at least a week prior to the procedure when they are send an appointment. On the day of procedure, either the Chief Investigator or one of the other two Investigators will see the patient in the Theatre Arrivals Area and have a full discussion on the details of the trial and will answer all their questions. Patients willing to take part and are within the inclusion criteria and does not have any of the exclusion criteria will be randomised to either the study group or the control group after obtaining informed consent.

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. ;

Related Conditions & MeSH terms

• Donor Site Complication
• Skin Graft

• NCT number: NCT03992820
• Study type: Interventional
• Source: University Hospitals, Leicester
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Completion date: March 18, 2020