Evaluating the Impact of Interscalene Brachial Plexus Block on Sleep-disordered Breathing in Patients Undergoing Ambulatory Shoulder Surgery. A Two-arm, Prospective, Parallel, Double Blind Randomized -Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).
研究概览
简要总结
This is a randomized controlled trial evaluating the impact of interscalene block on worsening of upper airway collapse in sleep disordered breathing for patients undergoing ambulatory shoulder surgery.
详细描述
Sleep disordered Breathing (SDB), closely associated with obesity, is a highly prevalent, serious, and often unrecognized breathing disorder resulting from repeated upper airway collapse, decreased oxygen levels, and a very high risk of life threatening complications at the time of surgery. Current guidelines recommend using regional as opposed to general anesthesia in SDB patients to minimize risks and the use of strong narcotic medications. It is unclear whether interscalene block in use for analgesia (pain relief) may actually worsen the severity of SDB by invariably freezing the phrenic nerve, thereby temporarily paralyzing the diaphragm.
This novel clinical trial will examine whether or not ISB increases the rate of upper airway obstruction or collapse during sleep and other dangerous postoperative complications seen in patients with SDB following shoulder surgeries.
The Primary Objective of the study is to evaluate the impact of ISB on the oxygen desaturation index (sleep apnea severity) in untreated SDB patients undergoing ambulatory shoulder surgery compared to patients who do not receive ISB.
Secondary Objectives are: 1) To evaluate the impact of hemidiaphragmatic paresis on impairment in pulmonary function; 2) To evaluate the impact of impairment in pulmonary function on the oxygen desaturation index (ODI); 3) To assess the incidence of important perioperative clinical outcomes such as hypoxemia, recurrent respiratory events, delayed discharge, and resource utilization in SDB patients undergoing ambulatory shoulder surgery compared to patients who do not receive ISB; and 4) To assess important analgesia related outcomes such as: time to onset of pain, intraoperative and postoperative opioid consumption, hourly and daily VAS pain scores, opioid related side effects, patient satisfaction with analgesia, and presence/absence of nerve block complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
On the day of surgery, patients will be randomly assigned (1:1) to one of two groups according to a computer-generated list. The patients, the clinical care team (anesthesiologist providing intraoperative care, nurses, and surgeons), data collectors, outcome adjudicators, and the study statisticians will all remain blinded to randomization and group allocation. The anesthesiologist who will perform the intervention will be aware of group allocation, but the anesthesiologist providing intraoperative care will remain blinded. Situations such as patient refusal at any time of the study, any adverse event or complication necessitating withholding the intervention would result in voluntary un-blinding of study investigators.
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
- •Adult patients ( >18 to 80 years);
- •American Society of Anesthesiology (ASA) physical status I-IV;
- •Undergoing elective ambulatory shoulder surgery such as shoulder replacement, acromioplasty, rotator cuff repair, or Bankart procedure under general anesthesia.
排除标准
- •Past history of head, neck or thoracic surgery (e.g., OSA corrective surgery);
- •Pregnancy or lactation;
- •Phrenic nerve stimulators;
- •Local anesthetic allergy;
- •Previous diaphragmatic paralysis;
- •Inability to communicate with health care providers or the research personnel, inability to perform breathing maneuvers such as spirometry, or inability to follow instructions.
结局指标
主要结局
Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).
时间窗: Time of measurements will be at baseline (pre operatively) and within 24 hours post-operatively (night of surgery)
All patients will undergo a portable overnight oximetry study at home to establish the baseline oxygen saturation measured hourly. Oxygen Desaturation Index (ODI), which is defined as a 4% drop in oxygenation from the baseline, and calculated as events occurring per hour during the recording time; the minimum and mean oxygen saturation ; and the cumulative total of recoded time below an oxygen saturation of 90%, CT90). Patients with preoperative ODI with more than a score of 10 will be considered at risk of SDB. A change from baseline will be examined and compared between the two groups.
次要结局
- Change in amplitude of diaphragmatic excursion with breathing maneuvers, between before and after surgery (measured by ultrasound)(Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 10-15 minutes.)
- Post operative respiratory events(Within 24 hours of the time of surgery)
- Patient satisfaction with analgesia(8 hours and 24 hours after surgery.)
- Change in pulmonary function before and after surgery, as measured by bedside spirometry(Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 5-10 minutes.)
- Visual Analogue Scale (VAS) pain scores(8 hours and 24 hours after surgery.)
- Analgesia requirements(Day 1 of surgery.)