The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for 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
- 60
- 试验地点
- 2
- 主要终点
- Incidence of rebound pain
研究概览
简要总结
The rebound pain after nerve block could interfere with the patient's recovery and rehabilitation. It is not known how intravenous dexamethasone affects rebound pain. This study aims to evaluate the effect of intravenous dexamethasone on rebound pain after interscalene block for shoulder surgery.
详细描述
Shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has been wearing off. Rebound pain is a severe pain that occurs when the effect of a nerve block disappears in a patient during the postoperative period. The purpose of this study is to investigate whether the use of intravenous dexamethasone reduces rebound pain in patients recruiting for shoulder surgery with interscalene brachial plexus blockade.
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. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.
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)
盲法说明
Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Stomach ulcer
- •Ucontrolled Diabetes
- •Psychiatric disorders,
- •Pregnancy,
- •Severe obesity (body mass index > 35 kg/m2)
结局指标
主要结局
Incidence of rebound pain
时间窗: One week after surgery
Rebound pain is described as severe pain (NRS ≥ 7)
The difference of pain score before and after interscalene block resolution
时间窗: First 12 hours after interscalene block effect disappears
The difference in the pain score between when the block is working and when it has resolved. Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.
次要结局
- Analgesic consumption(Postoperative 48 hours)
- Interscalene block resolution time(Postoperative 24 hours)
- Number of Participants with Surgical infection(Postoperative 14 days)
- Quality of Recovery 15 Score(Postoperative day 1 and day 7)
- Glucose measurement(Postoperative 24th hour)
- Sleep Quality measured with Likert Scale(One week after surgery)
- Numeric Rating Scale pain score ( NRS)(Postoperative 48 hours)