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Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia

NCT03992820 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-12-06

No results posted yet for this study

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

Interventions

DEVICE

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.

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Rajshree Jayarajan · University Hospitals, Leicester

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-03-18
Completion
2020-03-18

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992820 on ClinicalTrials.gov