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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The primary outcome is pain of local anaesthetic injection after application of TENS or LA cream as measured by two Numeric Pain Rating Scale
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary outcome is pain of local anaesthetic injection after application of TENS or LA cream as measured by two Numeric Pain Rating Scale
时间窗: 10 minutes
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.
次要结局
- 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)