Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in pain level as assessed by the VAS.
研究概览
简要总结
Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. It is frequently associated with acute postoperative and chronic pain. Due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. However opioids have many side effects. Interventional treatment, such as transversus abdominis plain (TAP) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. The hypoalgesic effect of transcutaneous electric nerve stimulation (TENS) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. However it could be a promising part of multi-modal pain treatment for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on hernia specific quality of life (QoL) after Lichtenstein hernia repair.
Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.
Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late postoperative period.
Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.
Aim#4 To determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with TENS effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Elective Lichtenstein repair for primary hernia
- •Male gender
- •No TENS procedures in the past
- •American Society of Anesthesiologists physical status I or II
- •No cognitive, speaking, hearing or visual disturbances
- •No movement disorders
排除标准
- •Non Lithuanian speaker
- •Known allergy to a patch glue
- •Chronic use of non-steroidal anti inflammatory drugs or opioids
- •Neuropathic diseases
- •General contraindication for TENS procedures (such as skin disorders in site of electrodes application or pacemaker)
- •Not able to complete the questionnaires
结局指标
主要结局
Change in pain level as assessed by the VAS.
时间窗: 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Pain is assessed using a 100 mm handheld slide rule-type visual analogue scale (VAS) with values from 0 to 100 (0 = no pain, 100 = extreme pain) during lying, waking and getting out of bed. Total scores are averaged.
次要结局
- Change in pressure pain tolerance.(1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.)
- Depression status influence to TENS effectiveness.(2 days postoperative)
- Anxiety status influence to TENS effectiveness.(2 days postoperative)
- Pain catastrophizing influence to TENS effectiveness.(2 days postoperative)
- Change in overall quality of life.(1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.)
- Consumption of analgesic drugs.(2 days postoperative)
- Change in hernia specific quality of life.(1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.)
- Change in pressure pain threshold.(1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.)
研究者
Audrius Paršeliūnas
Principal Investigator
Lithuanian University of Health Sciences