Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Quality of Recovery-15 score
研究概览
简要总结
Transcutaneous Electrical Nerve Stimulation (TENS) has been reported to reduce postoperative pain scores and opioid consumption after postoperative. This study aims to evaluate the effect of TENS application on recovery quality after interscalene block for shoulder surgery.
详细描述
Shoulder rotator cuff repair and acromioplasty are associated with severe pain after surgery. Interscalene block (ISB) is the gold standard for shoulder surgery, but the block duration does not exceed 6-8 hours. In addition, after the resolution of ISB, patients experience severe pain and need high doses of opioids. Rebound pain is observed in the postoperative period after the effect of the nerve block abolition. Rebound pain affects the quality of recovery and sleep quality in postoperative.
Transcutaneous Electrical Nerve Stimulation (TENS) is a method of pain relief that uses cutaneously applied electrodes for delivering electrical signals to peripheral nerves through the intact skin. TENS is safe and effective for acute postoperative pain treatment. In addition, TENS has been used in anesthesia to treat postoperative nausea vomiting, and labor analgesia beyond providing analgesia.
We hypothesized that TENS application would reduce the incidence of rebound pain, reduce the need for postoperative opioids, and improve recovery and sleep quality.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing shoulder surgery
- •Having signed a written informed consent form,
排除标准
- •Inadequate indication for interscalene block (Coagulation disorder, local infection of block site, Diaphragmatic paralysis, Allergy to local anesthetics)
- •Neuropathic disorder
- •Severe cardiopulmonary disease
- •Systemic steroid use
- •Chronic opioids use
- •Ucontrolled Diabetes
- •Psychiatric disorders,
- •Pregnancy,
- •Severe obesity (body mass index > 35 kg/m2)
研究组 & 干预措施
Gruop Control
The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative Placebo-TENS applied.
干预措施: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Group TENS
The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative TENS applied.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
结局指标
主要结局
Quality of Recovery-15 score
时间窗: Postoperative 24th hour
Minimum value: 0, Maximum value: 150, higher scores mean better.
次要结局
- Opioid consumption(48 hours)
- The difference of pain score before and after interscalene block resolution(First 24 hours after interscalene block effect disappears)
- Number of Participants with Surgical infection(Postoperative 14 days)
- Quality of Recovery-15 score(postoperative day 2 and 7)
- Numerical Rating Scale(48 hours)
- Incidence of rebound pain(24 hours after surgery)
- Sleep Quality measured with Likert Scale(One week after surgery)