Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia (TENS-LA)

NHS Trust

Status: Terminated

Conditions: Donor Site Complication; Skin Graft

Treatments: Device: TENS machine; Combination Product: EMLA cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03992820

113691

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

TENS arm (trial arm)

Experimental group

Description:

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.

Treatment:

Device: TENS machine

EMLA arm (Control arm)

Other group

Description:

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.

Treatment:

Combination Product: EMLA cream